Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
NCT00878943
Last updated date
ABOUT THIS STUDY
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.
Study Location
The Institute of Medical Sciences, CARE Hospital
Hyderabad, Andra Pradesh, 500 001, India
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
NEED INFO?
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Advanced Information
| 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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2021 | |||