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

NCT00796510 | Terminated Phase 3 Results

• 1 other identifier: B1321002
• Study Type: interventional
• Target: 3
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Pulmonary Arterial Hypertension; Pulmonary Hypertension

Keywords

endothelin receptor antagonist (ETRA); sitaxsentan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24

  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)

  Baseline, Week 12 and ET (up to Week 18)

Study Arms (2)

Sitaxsentan

EXPERIMENTAL

Monotherapy arm

Drug: Sitaxsentan

Sitaxsentan and Sildenafil

EXPERIMENTAL

Combination treatment

Drug: Sitaxsentan and Sildenafil

Interventions

Sitaxsentan DRUG

Sitaxsentan = 100 mg tablet administered orally, once daily

Sitaxsentan

Sitaxsentan and Sildenafil DRUG

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

Sitaxsentan and Sildenafil

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously enrolled in B1321001 for at least 4 weeks.
• Previously enrolled in B1321003, discontinued from the study.
• Completed the B1321003 study as planned.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Fountain Valley, California, 92708, United States

Location

Pfizer Investigational Site

Cluj-Napoca, 400 001, Romania

Location

Pfizer Investigational Site

Kyiv, Ukraine

Location

Related Links

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

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Interventions

sitaxsentan; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Due to the premature termination only 3 participants were recruited into this study. No summarization or analysis was done.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 25, 2018
• Results First Posted: February 20, 2012

Record last verified: 2018-09

Locations

US (1); RO (1); UA (1)