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COMPLETEDPhase 3NCT00554619

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

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 adminis...

Lead sponsor: GlaxoSmithKline•11 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

GlaxoSmithKline

Age

All ages

Sex

ALL

Healthy Volunteers

No

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•Subjects who have been withdrawn from the Phase II/III study.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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 5, 2012Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment21

Start dateFeb 2008

Last updatedNov 5, 2012

Condition

Pulmonary Arterial Hypertension Hypertension, Pulmonary

Locations shown

GSK Investigational Site

Aichi

GSK Investigational Site

Hokkaido

GSK Investigational Site

Hokkaido

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2012Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions