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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00554619
• Date of registration: 05/11/2007
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Study to Evaluate GSK1325760A - a Long-Term Extension Study
• Scientific 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 -
• Date of first enrolment: February 2008
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00554619
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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- Subjects who have been withdrawn from the Phase II/III study.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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Hypertension, Pulmonary

Intervention(s)

Drug: GSK1325760A

Primary Outcome(s)

Number of Participants With Any Adverse Event [Time Frame: For 140.57 weeks at maximum, starting from Week 24]

Number of Participants With Adverse Events Categorized by Severity [Time Frame: For 140.57 weeks at maximum, starting from Week 24]

Secondary Outcome(s)

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 [Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 156.14)]

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 [Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)]

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 [Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 153)]

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 [Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 159.85)]

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 [Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)]

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 [Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156]

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 [Time Frame: Up to 164.14 weeks]

Secondary ID(s)

AMB107818

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/02/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00554619