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Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00323297
First received: May 5, 2006
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.


Condition Intervention Phase
Pulmonary Arterial Hypertension
 Drug: Bosentan
Drug: Sildenafil Citrate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Multicentre, Randomized, Double-Blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg TID Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (PAH).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in the total distance walked during 6 Minute Walk Time (6MWT) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to clinical worsening (TTCW) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Borg Dyspnoea Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in World Health Organization (WHO) Functional Class in Participants with Pulmonary Arterial Hypertension (PAH) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: September 2006
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: Bosentan
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Experimental: Active Drug: Sildenafil Citrate
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged 18 and over above with PAH and for which bosentan therapy is indicated according to national license
  • Subjects with a mean pulmonary artery pressure of >25mmHg and a pulmonary artery wedge pressure of <15mmHg at rest via right heart catheterization within 3 years prior to randomization.
  • Subjects whose baseline 6 Minute Walk Test distance is >100m and < 450m.

Exclusion Criteria:

  • PAH secondary to any aetiology including congenital heart disease other than those specified in the inclusion criteria
  • Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323297

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 28 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00323297     History of Changes
Other Study ID Numbers: A1481243
Study First Received: May 5, 2006
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Bosentan
Sildenafil
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013