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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

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. Identifier: NCT00796510
Recruitment Status : Terminated (Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury)
First Posted : November 24, 2008
Results First Posted : February 20, 2012
Last Update Posted : October 25, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Pulmonary Hypertension Drug: Sitaxsentan Drug: Sitaxsentan and Sildenafil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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
Study Start Date : July 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00796510

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United States, California
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
Pfizer Investigational Site
Cluj Napoca, Romania, 400 001
Pfizer Investigational Site
Kyiv, Ukraine
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT00796510    
Other Study ID Numbers: B1321002
First Posted: November 24, 2008    Key Record Dates
Results First Posted: February 20, 2012
Last Update Posted: October 25, 2018
Last Verified: September 2018
Keywords provided by Pfizer:
endothelin receptor antagonist (ETRA)
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Endothelin Receptor Antagonists