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| Sponsored by: |
Pfizer |
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00644605 |
Purpose
To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.
| Condition | Intervention | Phase |
|
Hypertension, Pulmonary |
Drug: sildenafil Drug: placebo |
Phase III |
| Genetics Home Reference related topics: | pulmonary arterial hypertension |
| MedlinePlus related topics: | Exercise and Physical Fitness High Blood Pressure Pulmonary Hypertension |
| ChemIDplus related topics: | Sildenafil citrate Sildenafil |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multinational, Multi-Centre, Randomised, Double-Blind, Double-Dummy, Placebo-Controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over |
| Estimated Enrollment: | 275 |
| Study Start Date: | October 2002 |
| Study Completion Date: | November 2003 |
| Arms | Assigned Interventions |
| Arm 1: Active Comparator |
Drug: sildenafil
sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
|
| Arm 2: Active Comparator |
Drug: sildenafil
sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
|
| Arm 3: Active Comparator |
Drug: sildenafil
sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
|
| Arm 4: Placebo Comparator |
Drug: placebo
placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.
Exclusion Criteria:
Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.
Contacts and Locations![]() |
Show 68 Study Locations |
| Pfizer |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
To obtain contact information for a study center near you, click here. 
  |
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A1481140 |
| First Received: | March 20, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00644605 |
| Health Authority: | United States: Food and Drug Administration |
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