Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
NCT00878943
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Adult Trials: 18+ Years
- Subject who complete the A1481244 study and require Sildenafil (Revatio TM) 20 mg TID therapy.
- All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study
- Pregnant or lactating women
- Participation in other studies during study participation
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study | |||
| Brief Summary | In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. This protocol provides mechanism for patients who have clinical deterioration on other PAH approved therapies to have access to sildenafil prior to marketing authorization in India. | |||
| Detailed Description | Not Provided | |||
| Study Type | Expanded Access | |||
| Intervention | Drug: Sildenafil citrate
20 mg tablet to be taken thrice daily for 1 year | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Expanded Access Status | No longer available | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | India | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00878943 | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2017 | |||