A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension

NCT00667719 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CSAH100A23012008-001242-10
• Study Type: interventional
• Target: 564
• Locations: 8 countries
• Sites: 8

Brief Summary

This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.

Conditions

Essential Hypertension

Keywords

Essential hypertension; High blood pressure

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death

  An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.

  54 weeks

Secondary Outcomes (5)

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

  Baseline, Weeks 28 and 54 endpoint

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

  Baseline, Weeks 28 and 54 endpoints

• Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg

  Weeks 28 and 54 endpoints

• Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure

  Weeks 28 and 54 endpoints

• Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure

  Weeks 28 and 54 endpoints

Study Arms (1)

Aliskiren/Amlodipine/Hydrochlorothiazide

EXPERIMENTAL

Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.

Drug: Aliskiren; Drug: Amlodipine; Drug: Hydrochlorothiazide

Interventions

Aliskiren DRUG

300 mg tablet

Aliskiren/Amlodipine/Hydrochlorothiazide

Amlodipine DRUG

5 mg tablet

Aliskiren/Amlodipine/Hydrochlorothiazide

Hydrochlorothiazide DRUG

12.5 mg and 25 mg capsule

Aliskiren/Amlodipine/Hydrochlorothiazide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients 18 years of age or older
• Male or female participants are eligible.
• Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure (msSBP) Requirements:
• For newly diagnosed/untreated participants, msDBP ≥ 100 and \< 120 millimeters of mercury (mmHg), and/or msSBP ≥ 160 and \< 200 mmHg at Visit 1 and Visit 2.
• For previously treated participants, msDBP ≥ 100 and \< 120 mmHg, and/or msSBP ≥ 160 and \< 200 mmHg at Visit 2, Visit 3, or Visit 4.
• For participants requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.
• Participants who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

You may not qualify if:

• Inability to discontinue all prior antihypertensive medications safely for a period of 1 week to 4 weeks as required by the protocol.
• Participants on three antihypertensive drugs with msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg at Visit 1.
• Participants on four or more antihypertensive drugs at Visit 1.
• Participants with an msSBP ≥ 200 and msDBP ≥ 120 mmHg anytime during the washout period of the study Visit 1-4 must be discontinued from the study.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\>= 5 milli-international units per milliliter mIU/mL).

Sponsors & Collaborators

• Novartis: lead

Study Sites (8)

Investigative Site

Houston, Texas, United States

Location

Investigative Site

Belgium, Belgium

Location

Investigative Site

Egypt, Egypt

Location

Investigative Site

Germany, Germany

Location

Investigative Site

Poland, Poland

Location

Investigative Site

Slovakia, Slovakia

Location

Investigative Site

Spain, Spain

Location

Investigative Site

Turkey, Turkey (Türkiye)

Location

Related Publications (1)

• Murray AV, Koenig W, Garcia-Puig J, Patel S, Uddin A, Zhang J. Safety and efficacy of aliskiren/amlodipine/hydrochlorothiazide triple combination in patients with moderate to severe hypertension: a 54-week, open-label study. J Clin Hypertens (Greenwich). 2012 Dec;14(12):821-7. doi: 10.1111/j.1751-7176.2012.00706.x. Epub 2012 Aug 28.

  PMID: 23205748 RESULT

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

aliskiren; Amlodipine; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: June 5, 2008
• Primary Completion: October 5, 2009
• Study Completion: October 5, 2009
• Last Updated: June 7, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-05

Locations

DE (1); PL (1); BE (1); SL (1); US (1); ES (1); TU (1); EG (1)