Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00159887

First received: September 8, 2005

Last updated: June 7, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

June 7, 2011

Start Date ^ICMJE

December 2002

Primary Completion Date

Not Provided

Current Primary 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 Primary Outcome Measures ^ICMJE

Quality of life, as measured by the SF-36
Safety
Standard safety data
Efficacy
6-Minute Walk test at each visit
BORG Dyspnoea score at each visit
Pulmonary hypertension criteria for functional capacity and therapeutic class assessment at each visit

Change History

Complete list of historical versions of study NCT00159887 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

Official Title ^ICMJE

A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.

Brief Summary

Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Hypertension

Intervention ^ICMJE

Drug: Sildenafil citrate

Study Arm (s)

Not Provided

Publications *

Rubin LJ, Badesch DB, Fleming TR, Galiè N, Simonneau G, Ghofrani HA, Oakes M, Layton G, Serdarevic-Pehar M, McLaughlin VV, Barst RJ; SUPER-2 Study Group. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study. Chest. 2011 Nov;140(5):1274-83. Epub 2011 May 5.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

260

Completion Date

February 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with PAH who had completed the 12 week pivotal study

Exclusion Criteria:

Any other patients with PAH that had not been included into the pivotal study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Brazil, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Singapore, South Africa, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00159887

Other Study ID Numbers ^ICMJE

A1481142

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2011

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

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