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

This study has been terminated.
(Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00796510
First Posted: November 24, 2008
Last Update Posted: February 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Pulmonary Arterial Hypertension Pulmonary Hypertension Drug: Sitaxsentan Drug: Sitaxsentan and Sildenafil Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Baseline and every 12 weeks up to Week 18 ]
    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.


Secondary Outcome Measures:
  • 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) ]
    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.

  • 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) ]
    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).


Enrollment: 3
Study Start Date: July 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitaxsentan
Monotherapy arm
Drug: Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily
Experimental: Sitaxsentan and Sildenafil
Combination treatment
Drug: Sitaxsentan and Sildenafil
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796510


Locations
United States, California
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
Romania
Pfizer Investigational Site
Cluj Napoca, Romania, 400 001
Ukraine
Pfizer Investigational Site
Kyiv, Ukraine
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00796510     History of Changes
Other Study ID Numbers: B1321002
First Submitted: November 20, 2008
First Posted: November 24, 2008
Results First Submitted: December 9, 2011
Results First Posted: February 20, 2012
Last Update Posted: February 20, 2012
Last Verified: April 2011

Keywords provided by Pfizer:
endothelin receptor antagonist (ETRA)
sitaxsentan

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Sitaxsentan
Endothelin Receptor Antagonists
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents