To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00430716

Purpose

To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Sildenafil citrate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multinational, Multicentre, Randomized, Parallel Group, Double-Blind Study To Assess The Efficacy and Safety Of 1 mg, 5 mg and 20 mg TID of Oral Sildenafil in the Treatment of Subjects Aged 18 Years and Over With Pulmonary Arterial Hypertension (PAH)

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

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

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The change from baseline in the total distance walked during the 6MWT at Week 12 of the study. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline at Week 12 in the pulmonary hypertension criteria for functional capacity and therapeutic class. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Change from baseline at Week 12 in BNP and pro-BNP levels. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Change from baseline at Week 12 in the BORG dyspnoea score. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Change from baseline at Week 12 in mean pulmonary artery pressure (mPAP). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Time from randomization to the first occurrence of clinical worsening defined as death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy. [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	219
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sildenafil High dose: Experimental	Drug: Sildenafil citrate oral, 20 mg, tid
Sildenafil Low dose: Experimental	Drug: Sildenafil citrate oral 1 mg, tid
Sildenafil medium dose: Experimental	Drug: Sildenafil citrate oral 5 mg, tid
Sildenafil - Open label Phase: Experimental Open label extension from week 12 to week 24.	Drug: Sildenafil citrate oral 20 mg, tid

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute walk test distance is >/= 100 m and </= 450 m.
Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery wedge pressure of </= 15 mmHg at rest via right heart catheterization performed within 12 weeks prior to randomization.

Exclusion Criteria:

Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or significant arthritis.
Subjects who are currently receiving any forms of chronic treatment for PAH such as prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers. Subjects previously receiving any of these drugs must have stopped use for a period of at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3 months).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430716

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 52 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1481244
Study First Received:	January 31, 2007
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00430716 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vasodilator Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Citric Acid
Hematologic Agents
Vascular Diseases
Enzyme Inhibitors
Sildenafil
Cardiovascular Agents

Pharmacologic Actions
Phosphodiesterase Inhibitors
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Therapeutic Uses
Cardiovascular Diseases
Chelating Agents
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010