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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Intervention: GSK1325760A (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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)

Clinical Details

Official title: Study AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study -

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants With Any Adverse Event

Number of Participants With Adverse Events Categorized by Severity

Secondary outcome:

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

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

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

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

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

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

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

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Aichi 470-1192, Japan

GSK Investigational Site, Hokkaido 060-8543, Japan

GSK Investigational Site, Hokkaido 060-8648, Japan

GSK Investigational Site, Ishikawa 920-8641, Japan

GSK Investigational Site, Kanagawa 252-0375, Japan

GSK Investigational Site, Kyoto 606-8507, Japan

GSK Investigational Site, Okayama 701-1192, Japan

GSK Investigational Site, Okinawa 901-0243, Japan

GSK Investigational Site, Osaka 565-8565, Japan

GSK Investigational Site, Tokyo 113-8655, Japan

GSK Investigational Site, Tokyo 160-8582, Japan

Additional Information

Starting date: February 2008
Last updated: November 1, 2012

Page last updated: August 23, 2015

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