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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00430716
• Date of registration: 31/01/2007
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
• Scientific title: A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
• Date of first enrolment: April 8, 2008
• Target sample size: 130
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00430716
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

Belgium, Brazil, Bulgaria, China, Denmark, Greece, India, Italy, Latvia, Malaysia, Netherlands, Panama, Philippines, Poland, Romania, Russian Federation, Thailand, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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
- Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery
wedge pressure of 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Sildenafil citrate

Primary Outcome(s)

Change From Baseline in the Total Distance Walked During 6-Minute Walk Test (6MWT) at Week 12 [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Change From Baseline in BORG Dyspnoea Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 12 [Time Frame: Baseline and Week 12]

Number of Participants With Change From Baseline in PAH Criteria for Functional Capacity and Therapeutic Class at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in TAPSE Measurement at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in B-Type Natriuretic Peptide (BNP) at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Pro-BNP at Week 12 [Time Frame: Baseline and Week 12]

Number of Participants With Clinical Worsening [Time Frame: Baseline through Week 12]

Secondary ID(s)

2006-006748-76

A1481244

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/05/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00430716