"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"

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. - Not applicable

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000183

Enrollment

180

Registered

2009-05-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pulmonary Arterial Hypertension

Interventions

Intervention1: Sitaxsentan: 100 mg tablet administered orally, once daily Control Intervention1: Sitaxsentan and Sildenafil: Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil

Eligibility

Inclusion criteria

Inclusion criteria: Ages Eligible for Study: 16 Years to 80 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No 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

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.

Design outcomes

Primary

Measure	Time frame
The primary objective is to evaluate the long-term safety in subjects with PAH who are eligible for this study if B1321003 was completed, if early escape was met in B1321001, or early discontinuation in B1321003.Timepoint: Throughout	—

Secondary

Measure	Time frame
The secondary objective is to evaluate the efficacy in subjects with PAH who are eligible for this study if B1321003 was completed, if early escape was met in B1321001, or early discontinuation in B1321003 by determining change in 6MWD.Timepoint: Baseline/Day 1 to Weeks 12 and 24	—

Countries

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

Contacts

Public ContactSwapnali Raut

Representing Pfizer Limited

Swapnali.raut@pfizer.com91-9821415224

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026