The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH - Tabular View

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

April 4, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The change from Baseline in the total distance walked during the 6-Minute Walk test at Week 16 of the study.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00159861 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety Standard safety data Efficacy 6-Minute Walk Test BORG Dyspnoea Score WHO Functional Class Quality of Life SF-36 and EQ-5D

Original Secondary Outcome Measures ^ICMJE

Secondary Endpoints:
1. Change from Baseline at Week 16 in mean Pulmonary Artery Pressure (mPAP).
2. Time from randomisation to the first occurrence of clinical worsening defined as death or lung transplantation or hospitalisation due to PAH

Descriptive Information

Brief Title ^ICMJE

The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH

Official Title ^ICMJE

A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.

Brief Summary

Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Pulmonary Hypertension

Intervention ^ICMJE

Drug: Sildenafil citrate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

265

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with pulmonary arterial hypertension caused by primary PAH, associated with connective tissue disease or following surgical repair of a congenital heart lesion

Exclusion Criteria:

PH other than PAH

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, Czech Republic, Denmark, France, Israel, Italy, Netherlands, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00159861

Responsible Party

Director, Clinical Trial Disclosure, Pfizer, Inc.

Study ID Numbers ^ICMJE

A1481141

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP