Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

Viatris

Status and phase: Completed; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Bosentan; Drug: Sildenafil Citrate; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00323297

PATHWAYS (Other Identifier)

2006-001464-23 (EudraCT Number)

A1481243

Details and patient eligibility

About

To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged 18 and over above with PAH and for which bosentan therapy is indicated according to national license
• Subjects with a mean pulmonary artery pressure of >25mmHg and a pulmonary artery wedge pressure of <15mmHg at rest via right heart catheterization within 3 years prior to randomization.
• Subjects whose baseline 6 Minute Walk Test distance is >100m and < 450m.

Exclusion criteria

• PAH secondary to any aetiology including congenital heart disease other than those specified in the inclusion criteria
• Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

105 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Other: Placebo

Drug: Bosentan

Drug: Bosentan

Active

Experimental group

Treatment:

Drug: Bosentan

Drug: Sildenafil Citrate

Drug: Bosentan