A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01204853
• Date of registration: 06/08/2010
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
• Scientific title: A Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension
• Date of first enrolment: August 2010
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01204853
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has a current diagnosis of symptomatic PAH

- Has 6MWT distances from 150 to 450 meters and distance

Exclusion Criteria:

- Previous exposure to an endothelin receptor antagonist

- Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure
>160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening.

- Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5
minutes at Screening.



Age minimum: 16 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: Sitaxentan

Primary Outcome(s)

Change From Baseline in 6-minute Walk Distance [Time Frame: 12 weeks]

Number of Participants With Adverse Events [Time Frame: 12 weeks]

Secondary Outcome(s)

Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) [Time Frame: 12 weeks]

Number of Participants With Pharmacokinetic (PK) Parameters at Steady State [Time Frame: pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination]

Change From Baseline in WHO Functional Class [Time Frame: 12 weeks]

Clinical Worsening [Time Frame: 12 weeks]

Number of Participants With Haemodynamics Parameters [Time Frame: 12 weeks]

Secondary ID(s)

B1321052

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/12/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01204853