Overview

A Study to Evaluate GSK1325760A - a Long-Term Extension Study

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
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- Subjects who have been withdrawn from the Phase II/III study.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.