Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00796510
• Date of registration: 20/11/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
• Scientific title: A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension
• Date of first enrolment: July 2010
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00796510
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Bulgaria, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, India, Mexico, Peru, Philippines, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Thailand, Ukraine, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Previously enrolled in B1321001 for at least 4 weeks.

- Previously enrolled in B1321003, discontinued from the study.

- Completed the B1321003 study as planned.

Exclusion Criteria:

- Treated with an investigational drug (other than sitaxsentan or sildenafil in either
B1321001 or B1321003) or device that has not received regulatory approval within the
30 days prior to Baseline/Day 1 or during the study.



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

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Pulmonary Hypertension

Intervention(s)

Drug: Sitaxsentan and Sildenafil

Drug: Sitaxsentan

Primary Outcome(s)

Overall Survival [Time Frame: Baseline and every 12 weeks up to Week 18]

Secondary Outcome(s)

Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24 [Time Frame: Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)]

Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH) [Time Frame: Baseline, Week 12 and ET (up to Week 18)]

Secondary ID(s)

B1321002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/02/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00796510