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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159887
First Posted: September 12, 2005
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

Condition Intervention Phase
Pulmonary Hypertension Drug: Sildenafil citrate Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Enrollment: 260
Study Start Date: December 2002
Study Completion Date: February 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159887


  Show 65 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00159887     History of Changes
Other Study ID Numbers: A1481142
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: June 8, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Citric Acid
Sildenafil Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents