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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Hypertension, Pulmonary

Pulmonary Arterial Hypertension

Treatments

Drug: GSK1325760A

Study type

Interventional

Funder types

Industry

Identifiers

AMB107818

Details and patient eligibility

About

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)

Enrollment

21 patients

Sex

All

Volunteers

No Healthy Volunteers

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Subjects who have been withdrawn from the Phase II/III study.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.