Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529

NCT01342952 | Completed Phase 2 Results DMC

• 2 other identifiers: 1145882010-021572-29
• Study Type: interventional
• Target: 38
• Locations: 9 countries
• Sites: 22

Brief Summary

An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months. Beyond the six month period, subjects may continue in the extension study until one of the following conditions is met: the subject turns 18 years of age (when the subject can receive marketed product) the product is approved and available for use in the subject's age group, development for use in the paediatric population is discontinued. the subject decides he/she no longer wants to participate in the study, the investigator considers it is in the best interest of the subject to discontinue ambrisentan (e.g. for safety reasons). The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population. Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters.

Conditions

Hypertension, Pulmonary

Keywords

pulmonary arterial hypertension; pediatrics

Outcome Measures

Primary Outcomes (47)

• Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)

  AE was defined as any untoward medical occurrence in participant or clinical investigation participant,temporally associated with use of medicinal product, whether or not considered related to medicinal product.SAE was defined as any untoward medical occurrence that, at any dose: results in death,is life threatening, requires hospitalization or prolongation of existing hospitalization,results in disability or incapacity,or is congenital anomaly or birth defect, important medical events that may not immediately life threatening or result in death or hospitalization but may jeopardize participant or may require medical or surgical intervention as per medical or scientific judgement or associated with drug-induced liver injury.TEAE is any event that was not present prior to initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs which were not serious TEAEs were considered as non serious TEAEs.

  Up to 10 years and 11 months

• Change From Baseline in Liver Function Parameters: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin

  Blood samples were collected from participants for analysis of following clinical chemistry parameters: ALT, AST, GGT, total bilirubin. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Chemistry Parameters: Calcium, Chloride, Carbon Dioxide (CO2) Content, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Blood Urea Nitrogen (BUN)

  Blood samples were collected from participants for analysis of following clinical chemistry parameters: Calcium, chloride, CO2 content, glucose, potassium, magnesium, sodium, phosphorus inorganic, and BUN. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)

  Blood samples were collected from participants for analysis of following clinical chemistry parameters: ALP, CK, LDH. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Chemistry Parameters: Creatinine, Uric Acid

  Blood samples were collected from participants for analysis of following clinical chemistry parameters: Creatinine, uric acid. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Chemistry Parameters: Albumin, Total Protein

  Blood samples were collected from participants for analysis of following clinical chemistry parameters: Albumin, total protein. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)

  Blood samples were collected from participants for analysis of following hematology parameters: Hemoglobin and MCHC. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Hematology Parameters: Hematocrit

  Blood samples were collected from participants for analysis of following hematology parameters: Hematocrit. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC), Platelet Count

  Blood samples were collected from participants for analysis of following hematology parameters: Basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC, platelet count. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin

  Blood samples were collected from participants for analysis of following hematology parameter: Mean Corpuscle Hemoglobin. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Hematology Parameter: Mean Corpuscle Volume

  Blood samples were collected from participants for analysis of following hematology parameter: Mean Corpuscle Volume. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Hematology Parameters: Red Blood Cell Count, Reticulocytes

  Blood samples were collected from participants for analysis of following hematology parameters: Red Blood Cell count, reticulocytes. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Number of Participants With Abnormal Values for Physical Examination Parameter: Liver Size

  Physical examination included measurement of liver size. Any abnormal enlargement or reduction in the size of the liver is reported. Liver size was assessed as normal or abnormal. Data for abnormal (improved, worsened and unchanged) liver size is presented. End of study visit data is presented.

  Up to 10 years and 11 months

• Number of Participants With Abnormal Values for Physical Examination Parameter: Jugular Venous Pressure

  Physical examination included measurement of Jugular venous pressure. Jugular venous pressure was assessed as normal or abnormal. Data for abnormal (improved, worsened and unchanged) jugular venous pressure is presented. End of study visit data is presented.

  Up to 10 years and 11 months

• Number of Participants With Abnormal Values for Physical Examination Parameters: Ascites

  Physical examination included measurement of ascites. Ascites were assessed as present or absent. Data for ascites present with improved, worsened and unchanged is presented. End of study visit data is presented.

  Up to 10 years and 11 months

• Number of Participants With Abnormal Values for Physical Examination Parameter: Peripheral Edema

  Physical examination included measurement of peripheral edema. Peripheral edema were assessed as present or absent. Data for peripheral edema present with improved, worsened and unchanged is presented. End of study visit data is presented.

  Up to 10 years and 11 months

• Percentage of Saturated Oxygen Level (Physical Examination Parameter)

  Physical examination included measurement of saturated oxygen. End of study visit data is presented.

  Up to 10 years and 11 months

• Change From Baseline in Vital Signs Parameter: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

  SBP and DBP was measured for the participants at indicated time points. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Vital Signs Parameter: Heart Rate

  Heart rate was measured for the participants at indicated time points. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Vital Signs Parameter: Weight

  Weight was measured for the participants at indicated time points. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Vital Sign Parameter: Height

  Height was measured for the participants at indicated time points. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Vital Sign Parameter: Body Mass Index

  Body mass index was measured for the participants at indicated time points. Body mass index was calculated as weight in kilograms (kg) divided by the square of their height in meters (m\^2). Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Vital Sign Parameter: Body Surface Area

  Body surface area was measured for the participants at indicated time points. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Number of Participants With Abnormal Electrocardiogram (ECG) Findings

  12-lead ECG was measured in a semi-supine position using an automated ECG machine. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Data for any time till end of study were presented.

  Up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Female: Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at End of Study

  FSH and LH level of participants were measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Female: Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at 20 Years of Age of Participants

  FSH and LH level of participants were measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants.

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline in Plasma Endocrine Parameters - Female: Inhibin B at End of Study

  Inhibin B level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Female: Inhibin B at 20 Years of Age of Participants

  Inhibin B level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants.

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline in Plasma Endocrine Parameters - Female: Sex Hormone Binding Globulin at End of Study

  Sex hormone binding globulin level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Female: Sex Hormone Binding Globulin at 20 Years of Age of Participants

  Sex hormone binding globulin level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants.

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline in Plasma Endocrine Parameters - Female: Estrone at End of Study

  Estrone level of female participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Female: Estrone at 20 Years of Age of Participants

  Estrone level of female participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants.

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline in Plasma Endocrine Parameters - Female: Estriol at End of Study

  Estriol level of female participants will be measured. Only those parameters having status as overall will be presented. Baseline is the last value recorded prior to start of study treatment from AMB112529. Change from Baseline is calculated by subtracting the Baseline value from the end of study post-dose visit value. Data for this endpoint will be available for this endpoint by June 2023

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Female: Estriol at 20 Years of Age of Participants

  Estriol level of female participants will be measured. Only those parameters having status as overall will be presented. Baseline is the last value recorded prior to start of study treatment from AMB112529.Change from Baseline is calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. Data for this endpoint will be available for this endpoint by June 2023

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline in Plasma Endocrine Parameters - Female: Estradiol at End of Study

  Estradiol level of female participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Female: Estradiol at 20 Years of Age of Participants

  Estradiol level of female participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants.

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline in Plasma Endocrine Parameters - Male: FSH and LH at End of Study

  FSH and LH level of participants were measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Male: FSH and LH at 20 Years of Age of Participants

  FSH and LH level of participants were measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants.

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline in Plasma Endocrine Parameters - Male: Inhibin B at End of Study

  Inhibin B level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Male: Inhibin B at 20 Years of Age of Participants

  Inhibin B level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants.

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline in Plasma Endocrine Parameters - Male: Sex Hormone Binding Globulin at End of Study

  Sex hormone binding globulin level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Male: Sex Hormone Binding Globulin at 20 Years of Age of Participants

  Sex hormone binding globulin level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants.

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline in Plasma Endocrine Parameters - Male: Total Testosterone at End of Study

  Total Testosterone level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline in Plasma Endocrine Parameters - Male: Total Testosterone at 20 Years of Age of Participants

  Total Testosterone level of participants was measured. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants.

  Baseline (Day 1) and at 20 years of age of participants

• Change From Baseline of Pubertal Development in Male: Testicular Volume at End of Study

  Testicular volume was assessed by Prader's orchiodometer and the assessment was performed by a pediatric endocrinologist using the Tanner's criteria. Only those parameters having status - overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. Data reported for left and right testicular volume.

  Baseline (Day 1) and up to 10 years and 11 months

• Change From Baseline of Pubertal Development in Male: Testicular Volume at 20 Years of Age of Participants

  Testicular volume was assessed by Prader's orchiodometer and the assessment was performed by a pediatric endocrinologist using the Tanner's criteria. Only those parameters having status as overall were presented. Baseline was the last value recorded prior to start of study treatment from AMB112529.Change from Baseline was calculated by subtracting the Baseline value from the specified time point value. Only participants with data at 20 year visit is presented. When participants reached pubertal maturity prior to being 20 years of age then these tests were not repeated at 20-years of age of participants. Data reported for left and right testicular volume.

  Baseline (Day 1) and at 20 years of age of participants

• Time to Change in Dose of Ambrisentan or Other Targeted PAH Therapeutic Agents (Prostanoids, Phosphodiesterase Type 5 [PDE-5] Inhibitors) Due to Tolerability Issues

  Time to change in dose of ambrisentan or other targeted PAH therapeutic agents (prostanoids, Phosphodiesterase type 5 \[PDE-5\] inhibitors) due to tolerability issues was defined as the time from randomization to the first occurrence of a dose change due to tolerability issues.

  Baseline (Day 1) and up to 10 years and 11 months

Secondary Outcomes (9)

• Number of Participants With All-cause Death

  Up to 10 years and 11 months

• Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test

  Baseline (Day 1) and up to 10 years and 11 months

• Time to the First Clinical Worsening of PAH

  Up to 10 years and 11 months

• Time to the Addition of Another Targeted PAH Therapeutic Agent Due to Deterioration of Clinical Condition

  Up to 10 years and 11 months

• Time to the Addition of Another Targeted PAH Therapeutic Agent Due to Lack of Beneficial Effect With Previous Therapy

  Up to 10 years and 11 months

Study Arms (1)

Ambrisentan

EXPERIMENTAL

Open label, flexible dosing from 2.5 mg to 10 mg (not to exceed 0.25 mg/kg) per day

Drug: Ambrisentan

Interventions

Ambrisentan DRUG

open label, flexible dosing from 2.5 to 10 mg (not to exceed 10 mg/kg) per day

Ambrisentan

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have participated in and complied, to the best of their ability, with the protocol for AMB112529 and have met one of the following:
• Completed the Week 24 visit in AMB112529;
• Required additional targeted treatment for PAH due to inadequate response to the current treatment or worsening of their clinical condition prior to week 24 in AMB112529;
• Required reduction in dose of baseline targeted treatment for PAH after ambrisentan was added to the treatment regimen;
• In the opinion of the investigator, continued treatment with ambrisentan is warranted.
• A female is eligible to participate in this study, as assessed by the investigator, if she is of:
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
• Child-bearing potential - has a negative pregnancy test and is not lactating and, if sexually active, agrees to continue to use 2 reliable methods of contraception until study completion and for at least 30 days following the last dose of study drug (reliable methods of contraception are listed in Appendix 2).
• Subject or subject's legal guardian is able and willing to give written informed consent. As part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.

You may not qualify if:

• Subjects who were withdrawn from ambrisentan in Study AMB112529;
• Subjects who did not comply with the protocol in Study AMB112529;
• Female subjects who are pregnant or breastfeeding;
• Subjects with severe renal impairment (estimated creatinine clearance \<30 mL/min assessed within the previous 45 days) at the point of transition from Study AMB112529 into this study;
• Subject with clinically significant fluid retention in the opinion of the investigator;
• Subject with clinically significant anaemia in the opinion of the investigator;
• Subjects who are to enter another clinical trial or be treated with another investigational product after exiting Study AMB112529.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (22)

GSK Investigational Site

Aurora, Colorado, 80045, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02115, United States

Location

GSK Investigational Site

Ann Arbor, Michigan, 48109-4204, United States

Location

GSK Investigational Site

New York, New York, 10032, United States

Location

GSK Investigational Site

Guymallen, Mendoza Province, 5521, Argentina

Location

GSK Investigational Site

Ciudad de Buenos Aires, 1118, Argentina

Location

GSK Investigational Site

Córdoba, 5000, Argentina

Location

GSK Investigational Site

Paris, 75015, France

Location

GSK Investigational Site

Pessac, 33604, France

Location

GSK Investigational Site

Toulouse, 31059, France

Location

GSK Investigational Site

Giessen, Hesse, 35385, Germany

Location

GSK Investigational Site

Berlin, 13353, Germany

Location

GSK Investigational Site

Budapest, 1096, Hungary

Location

GSK Investigational Site

Rome, Lazio, 00165, Italy

Location

GSK Investigational Site

San Donato Milanese (MI), Lombardy, 20097, Italy

Location

GSK Investigational Site

Osaka, 565-0871, Japan

Location

GSK Investigational Site

Tokyo, 104-8560, Japan

Location

GSK Investigational Site

Tokyo, 143-8541, Japan

Location

GSK Investigational Site

Kemerovo, 650002, Russia

Location

GSK Investigational Site

Moscow, 125412, Russia

Location

GSK Investigational Site

Novosibirsk, 630055, Russia

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 27, 2011
• Study Start: June 21, 2011
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: December 30, 2022
• Results First Posted: December 30, 2022

Record last verified: 2022-12

Locations

RU (3); DE (2); FR (3); ES (1); AR (3); JP (3); HU (1); IT (2); US (4)