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

Pulmonary Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00796510
• Other study ID #: B1321002
• Status: Terminated
• Phase: Phase 3
• Start date: July 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension

Intervention

Drug:
• Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily
• Sitaxsentan and Sildenafil
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Locations

Country	Name	City	State
Romania	Pfizer Investigational Site	Cluj Napoca
Ukraine	Pfizer Investigational Site	Kyiv
United States	Pfizer Investigational Site	Fountain Valley	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.	Baseline and every 12 weeks up to Week 18
Secondary	Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24	The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline.	Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)
Secondary	Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)	The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms).	Baseline, Week 12 and ET (up to Week 18)

External Links

•   To obtain contact information for a study center near you, click here.