NCT00554619

Brief Summary

The primary objective of this study is to evaluate the safety of long-term administration of GSK1325760A in patients with PAH. The secondary objectives of this study are to evaluate long-term administration of GSK1325760A on:

  • Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO Functional Classification and time to clinical worsening of PAH
  • Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk test \[6MWT\])
  • Change in plasma brain natriuretic peptide (BNP) levels
  • Cardiopulmonary hemodynamics parameters (as measured by echocardiography)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2008

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 13, 2012

Completed
Last Updated

November 5, 2012

Status Verified

October 1, 2012

Enrollment Period

2.9 years

First QC Date

November 5, 2007

Results QC Date

October 20, 2011

Last Update Submit

November 1, 2012

Conditions

Pulmonary Arterial HypertensionHypertension, Pulmonary

Keywords

Pulmonary Arterial HypertensionAmbrisentan

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Any Adverse Event

    An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.

    For 140.57 weeks at maximum, starting from Week 24

  • Number of Participants With Adverse Events Categorized by Severity

    The severity of adverse events was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.

    For 140.57 weeks at maximum, starting from Week 24

Secondary Outcomes (7)

  • Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156

    Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156

  • Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion

    Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 159.85)

  • Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion

    Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)

  • Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event

    Up to 164.14 weeks

  • Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion

    Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 153)

  • +2 more secondary outcomes

Study Arms (1)

GSK1325760A

EXPERIMENTAL
Drug: GSK1325760A

Interventions

GSK1325760ADRUG

2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW.

GSK1325760A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who complete the 24-week administration of the Phase II/III study (Study No.AMB107816)
  • Subjects who are assessed that the long-term extension administration of GSK1325760A is appropriate in the judgement of the investigator or subinvestigator
  • Subjects who request the long-term extension administration of GSK1325760A, and agree to newly sign the informed consent form

You may not qualify if:

  • Subjects who have been withdrawn from the Phase II/III study.
  • Female subjects who wish to become pregnant.
  • Treatment with other PAH medication is needed.
  • A worsening of 2 or more levels of the WHO Functional Classification (see Appendix 2.1) comparing with the baseline of Phase II/III study (Study No.AMB107816).
  • Worsening of right ventricular failure (e.g. as indicated by increased jugular venous pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during Phase II/III study (Study No.AMB107816).
  • Rapidly progressing cardiac, hepatic or renal failure during Phase II/III study (Study No.AMB107816).
  • Participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

GSK Investigational Site

Aichi, 470-1192, Japan

Location

GSK Investigational Site

Hokkaido, 060-8543, Japan

Location

GSK Investigational Site

Hokkaido, 060-8648, Japan

Location

GSK Investigational Site

Ishikawa, 920-8641, Japan

Location

GSK Investigational Site

Kanagawa, 252-0375, Japan

Location

GSK Investigational Site

Kyoto, 606-8507, Japan

Location

GSK Investigational Site

Okayama, 701-1192, Japan

Location

GSK Investigational Site

Okinawa, 901-0243, Japan

Location

GSK Investigational Site

Osaka, 565-8565, Japan

Location

GSK Investigational Site

Tokyo, 113-8655, Japan

Location

GSK Investigational Site

Tokyo, 160-8582, Japan

Location

Related Publications (1)

  • Yoshida S, Shirato K, Shimamura R, Iwase T, Aoyagi N, Nakajima H. Long-term safety and efficacy of ambrisentan in Japanese adults with pulmonary arterial hypertension. Curr Med Res Opin. 2012 Jun;28(6):1069-76. doi: 10.1185/03007995.2012.685930. Epub 2012 May 15.

    PMID: 22506623DERIVED

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, Pulmonary

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
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 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 7, 2007

Study Start

February 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 5, 2012

Results First Posted

February 13, 2012

Record last verified: 2012-10

Locations

JP(11)