To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks
NCT00946114
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
1. Subjects aged 18 and over who have any of the following conditions:
- Idiopathic pulmonary arterial hypertension.
- PAH associated with connective tissue disease (CTD).
- PAH with surgical repair, at least 5yrs previously, of atrial septal defect (ASD), ventricular septal defect (VSD) patent ductus arteriosis (PDA) or aorta-pulmonary window.
2. Subjects with a mean pulmonary artery pressure (mPAP) > 25mmHg and a pulmonary artery wedge pressure (PAWP) < 15mmHg at rest, assessed via right heart catheterization.
3. Subjects whose baseline 6-min walk test distance was > 100m and < 450m.
1. PAH secondary to any etiology other than those specified in the inclusion criteria.
2. Subjects with congenital heart disease (other than those specified in the inclusion
criteria), PAH due to thrombo-embolism, HIV, chronic obstructive airways disease,
congestive heart failure.
3. Subjects whose 6-Minute Walk test might have been limited by conditions other than
PAH, associated dyspnea or fatigue.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Warszawa,
- Zabrze,
- Bruxelles,
- Birmingham, Alabama
- Birmingham, Alabama
- Birmingham, Alabama
- La Jolla, California
- La Jolla, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- San Diego, California
- Torrance, California
- Torrance, California
- Aurora, Colorado
- Denver, Colorado
- Chicago, Illinois
- Shreveport, Louisiana
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- Rochester, Minnesota
- New York, New York
- Durham, North Carolina
- Nashville, Tennessee
- Houston, Texas
- Milwaukee, Wisconsin
- Darlinghurst, New South Wales
- Melbourne, Victoria
- Bruxelles,
- Leuven,
- Sao Paulo, SP
- Prague 4,
- Prague 4,
- Kobenhavn,
- Clamart,
- Berlin,
- Giessen,
- Giessen,
- Hannover,
- Leipzig,
- Shatin N T,
- Budapest, Pest
- Zalaegerszeg, Zala
- Petach Tikva,
- Tel Hashomer,
- Bologna,
- Pisa,
- Pisa,
- Suwon,
- Kuala Lumpur,
- Tlalpan,
- Amsterdam,
- Oslo,
- Katowice,
- Warszawa,
- Warszawa,
- Zabrze,
- Singapore,
- Cape Town,
- Johannesburg,
- Parow,
- Barcelona,
- Barcelona,
- Madrid,
- Goteborg,
- Molndal,
- Papworth Everard, Cambridgeshire
- Sheffield, South Yorkshire
- Glasgow,
- High Heaton, Newcastle-upon-tyne,
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Gainesville, Florida
- Omaha, Nebraska
- Pittsburgh, Pennsylvania
- Dallas, Texas
- Dallas, Texas
- London, Ontario
- London, Ontario
- Montreal, Quebec
- Heidelberg,
- Hyderabad, Andhra Pardesh
- Tirupati, Andhra Pardesh
- Vadodara, Gujarat
- Mangalore, Karnataka
- Moscow,
- Moscow,
- Barcelona,
- Barcelona,
- Madrid,
- Lund,
- Umea,
- Uppsala,
- Zuerich,
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks | |||
| Official Title | A Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland. | |||
| Brief Summary | The purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study for the treatment of PAH in Poland. Only safety and tolerability data will be collected in these patients. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Other Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Expanded access | |||
| Condition | Pulmonary Hypertension | |||
| Intervention |
| |||
| Study Groups/Cohorts | Not Provided | |||
| 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 | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 32 | |||
| Original Enrollment | Not Provided | |||
| Actual Study Completion Date | March 2009 | |||
| Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Poland | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00946114 | |||
| Other Study ID Numbers | A1481242 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| 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 | |||