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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00866983 |
Purpose
The purpose of this study is to provide sildenafil therapy to patients who completed the A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil. It will be supplied until patient gets access to Sildenafil through Brazilian State Health Secretary from where patient resides.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Arterial Hypertension |
Drug: Sildenafil 20 mg TID |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil. |
| Estimated Enrollment: | 28 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sildenafil 20 mg TID: Experimental |
Drug: Sildenafil 20 mg TID
To provide access to sildenafil for patients completing the A1481244 study, resides in Brazilian States where Revatio™ is not supplied by Health Secretary and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil. It will be supplied until the patient gets access to Sildenafil through Brazilian State Health Secretary from where the patient resides.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A1481270 |
| Study First Received: | March 20, 2009 |
| Last Updated: | April 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00866983 History of Changes |
| Health Authority: | Brazil: NATIONAL ETHICS COMMITTEE (CONEP) |
|
Open label, sildenafil, PAH, Brazil |
|
Vasodilator Agents Phosphodiesterase Inhibitors Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Idiopathic Pulmonary Hypertension Vascular Diseases Sildenafil Cardiovascular Agents Hypertension |
|
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Vascular Diseases Sildenafil Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions |
Phosphodiesterase Inhibitors Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Therapeutic Uses Cardiovascular Diseases Hypertension |
