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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00323297
First received: May 5, 2006
Last updated: May 21, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
pulmonary arterial hypertension
MedlinePlus related topics:
High Blood Pressure
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
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Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Hide Study LocationsLocations
| United States, California | |
| Pfizer Investigational Site | Terminated |
| Los Angeles, California, United States, 90073 | |
| United States, Michigan | |
| Pfizer Investigational Site | Completed |
| Detroit, Michigan, United States, 48202 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Terminated |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Texas | |
| Pfizer Investigational Site | Completed |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | Terminated |
| San Antonio, Texas, United States, 78229 | |
| Australia, New South Wales | |
| Pfizer Investigational Site | Terminated |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Australia, Queensland | |
| Pfizer Investigational Site | Completed |
| Chermside, Queensland, Australia, 4032 | |
| Czech Republic | |
| Pfizer Investigational Site | Completed |
| Praha 2, Czech Republic, 128 08 | |
| Pfizer Investigational Site | Completed |
| Praha 4, Czech Republic, 140 21 | |
| France | |
| Pfizer Investigational Site | Recruiting |
| Lille, France, 59037 | |
| Pfizer Investigational Site | Completed |
| Vandoeuvre Les Nancy, France, 54511 | |
| Germany | |
| Pfizer Investigational Site | Completed |
| Berlin, Germany, 12683 | |
| Pfizer Investigational Site | Recruiting |
| Coburg, Germany, 96450 | |
| Pfizer Investigational Site | Recruiting |
| Essen, Germany, 45122 | |
| Pfizer Investigational Site | Completed |
| Giessen, Germany, 35392 | |
| Pfizer Investigational Site | Completed |
| Hannover, Germany, 30625 | |
| Pfizer Investigational Site | Recruiting |
| Homburg, Germany, 66421 | |
| Pfizer Investigational Site | Completed |
| Leipzig, Germany, 04103 | |
| Pfizer Investigational Site | Completed |
| Muenchen, Germany, 81377 | |
| Pfizer Investigational Site | Recruiting |
| Nuernberg, Germany, 90402 | |
| Pfizer Investigational Site | Recruiting |
| Wuerzburg, Germany, 97067 | |
| Greece | |
| Pfizer Investigational Site | Recruiting |
| Haidari, Athens, Greece, 12462 | |
| Israel | |
| Pfizer Investigational Site | Completed |
| Haifa, Israel, 31096 | |
| Pfizer Investigational Site | Completed |
| Petach Tikva, Israel, 49100 | |
| Italy | |
| Pfizer Investigational Site | Completed |
| Napoli, Italy, 80131 | |
| Pfizer Investigational Site | Completed |
| Roma, Italy, 00161 | |
| Taiwan | |
| Pfizer Investigational Site | Completed |
| Taipei, Taiwan, 100 | |
| United Kingdom | |
| Pfizer Investigational Site | Terminated |
| Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
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 June 18, 2013