Phase 3
Completed N=21
A Study to Evaluate GSK1325760A - a Long-Term Extension Study
Pulmonary Arterial Hypertension · Hypertension, Pulmonary
Source: ClinicalTrials.gov NCT00554619 ↗
Enrolled (actual)
21
Serious AEs
38.1%
Results posted
Feb 2012
Primary outcomePrimary: Number of Participants With Any Adverse Event — 21 participants
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event |
21 | — |
| PRIMARY Number of Participants With Adverse Events Categorized by Severity |
12; 5; 4 | — |
| SECONDARY 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 |
53.55; 51.90; 59.61; 46.38; 59.86; 58.11 | — |
| SECONDARY 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 |
-0.79; -0.57; -1.00; -1.00; -1.08; -1.31 | — |
| SECONDARY 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 |
10; 11; 0; 10; 11; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 1 | — |
| SECONDARY 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 |
-9.96; -8.16; -7.06; -5.44; -10.68; -9.23 | — |
| SECONDARY Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion |
0.425; 0.291; 0.227; 0.430; -0.002; 0.151 | — |
| SECONDARY Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion |
-109.54; -96.98; -70.40; -79.89; -81.36; -118.78 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00554619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.