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

Viatris

Status and phase: Terminated; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Sildenafil citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430716

A1481244

2006-006748-76 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 4 patient groups

Sildenafil High dose

Experimental group

Treatment:

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Sildenafil Low dose

Experimental group

Treatment:

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Sildenafil medium dose

Experimental group

Treatment:

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Sildenafil - Open label Phase

Experimental group

Description:

Open label extension from week 12 to week 24.

Treatment:

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Drug: Sildenafil citrate

Drug: Sildenafil citrate