A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00644605
• Date of registration: 20/03/2008
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension
• Scientific title: A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over
• Date of first enrolment: October 2002
• Target sample size: 275
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00644605
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

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

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

Included patients had primary pulmonary arterial hypertension, pulmonary hypertension
secondary to connective tissue disease, or pulmonary hypertension with surgical repair at
least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg
and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right
heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk
test distance of 100 m to 450 m.

Exclusion Criteria:

Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV,
chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects
with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary
regurgitation; and acutely decompensated heart failure within the previous 30 days;
subjects with pulmonary hypertension secondary to any other etiology other than those
specified in the inclusion criteria.



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

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: placebo

Drug: sildenafil

Primary Outcome(s)

Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test). [Time Frame: Week 12]

Secondary Outcome(s)

Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class [Time Frame: Week 12]

Patient overall preference assessment [Time Frame: Week 12]

Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression) [Time Frame: Week 4 and Week 12]

Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy) [Time Frame: Week 0 to 12]

Change from baseline in the BORG dyspnoea score [Time Frame: Week 12]

Change from baseline in hemodynamic parameters [Time Frame: Week 12]

Change from baseline in mean pulmonary arterial pressure [Time Frame: Week 12]

Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition) [Time Frame: Week 4 and Week 12]

Change in Chronic Use of Background Therapy for Pulmonary Arterial Hypertension [Time Frame: throughout the study]

Secondary ID(s)

A1481140

Source(s) of Monetary Support

Please refer to primary and secondary sponsors