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

Viatris

Status and phase: Completed; Phase 3

Conditions: Hypertension, Pulmonary

Treatments: Drug: placebo; Drug: sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644605

A1481140

Details and patient eligibility

About

To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

Enrollment: 275 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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275 participants in 4 patient groups, including a placebo group

Arm 1

Active Comparator group

Treatment:

Drug: sildenafil

Drug: sildenafil

Drug: sildenafil

Arm 2

Active Comparator group

Treatment:

Drug: sildenafil

Drug: sildenafil

Drug: sildenafil

Arm 3

Active Comparator group

Treatment:

Drug: sildenafil

Drug: sildenafil

Drug: sildenafil

Arm 4

Placebo Comparator group

Treatment:

Drug: placebo