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

September 8, 2005
June 7, 2011
December 2002
Not Provided
  • Safety
  • Standard safety data
  • Efficacy
  • 6-Minute Walk Test
  • BORG Dyspnoea Score
  • WHO Functional Class
  • Quality of Life SF-36 and EQ-5D
  • 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
Complete list of historical versions of study NCT00159887 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension
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.

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: Sildenafil citrate
Not Provided
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. doi: 10.1378/chest.10-0969. Epub 2011 May 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
February 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   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
 
NCT00159887
A1481142
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

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