Open Label Extension Study Evaluating Sildenafil Citrate When Used In Combination With Epoprostenol In Pulmonary Arterial Hypertension - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00147641

Purpose

Open label extension study evaluating the effects of sildenafil citrate when used in combination with epoprostenol in the treatment of PAH.

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Sildenafil citrate	Phase III

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Sildenafil citrate Sildenafil Citric acid Sodium Citrate Epoprostenol Epoprostenol sodium

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Multi-Centre, Multinational, Long-Term, Open-Label Extension Study, To Assess the Safety of Subject Optimised Treatment Regimens of Oral Sildenafil When Used In Combination With Intravenous Prostacyclin (Epoprostenol), for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481141.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Change in epoprostenol dose [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Survival status [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	265
Study Start Date:	November 2003
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open: Experimental	Drug: Sildenafil citrate Oral, 20, 40 or 80 mg three times a day (tid)

Eligibility

Criteria

Inclusion Criteria:

Patients need to have completed the 16 week double blind study A1481141

Exclusion Criteria:

Any subject that withdrew from study A1481141

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147641

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1481153
Study First Received:	September 4, 2005
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00147641
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Citric Acid

Epoprostenol
Vascular Diseases
Sildenafil
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Enzyme Inhibitors

Platelet Aggregation Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009