Evaluation of tolerability and efficacy of the combination Sildenafil/Bosentan in patients with severe pulmonary hypertension.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017155-10-IT

Enrollment

Registered

2011-12-06

Start date

2006-11-07

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe pulmonary hypertension MedDRA version: 14.0 Level: HLT Classification code 10037401 Term: Pulmonary hypertensions System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: VIAGRA Pharmaceutical Form: Coated tablet INN or Proposed INN: Sildenafil Concentration unit: mg milligram(s) Concentration number: 25- Trade Name: TRACLEER Pharmaceutical Form: Coated ta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria 1) Patients with idiopathic or familial pulmonary arterial hypertension (PAH) 2) Patients with distal Chronic Thromboembolic Pulmonary Hypertension 3) PAH associated to connective tissue disease, anorexigen, congenital heart disease. 4) Age > 18 years 5) Mean pulmonary pressure > 25 mmHg, mean pulmonary capillary ''wedge'' pressure =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1) Significant reduction in pulmonary function test (FVC, FEV1 3 fold upper normal limits 6) Pshyschiatric disease or other condition that will be an impediment to the protocol 7) Pregnancy or lactation 8) Known hypersensitivity to bosentan or sildenafil 9) Treatment with other drugs that could have significant interaction with bosentan or sildenafil: calcineurine inhibitors (ciclosporine tacrolimus…), antimycotics (fluconazole, chetoconazole…), amiodarone, antiretroviral drug, glibencamide, nitrates, alfa-blockers.

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to evaluate the tolerability and clinical efficacy of an oral combination therapy Bosentan-Sildenafil, in patients with severe pulmonary hypertension due to PAH or distal chronic thromboembolic pulmonary hypertension.;Secondary Objective: The study will be extended also to patients with distal CTEPH because: - These patients present, beside proximal vessels obstruction, with distal lesion involving small and medium size pulmonary arteries similar to other form of severe pulmonary hypertension. - Furthermore an open uncontrolled study suggest beneficial hemodynamic effect after epoprostenol , sildenafil and bosentan therapy.;Primary end point(s): Primary endpoints will be: - Improvement of functional capacity compared to the basal conditions and to the period of monotherapy evaluated through distance 6 minutes walking test. - Improvement of the quality of life (WHOQOL-BRIEF questionnaire)	—

Measure

Time frame

Main Objective: The purpose of this study is to evaluate the tolerability and clinical efficacy of an oral combination therapy Bosentan-Sildenafil, in patients with severe pulmonary hypertension due to PAH or distal chronic thromboembolic pulmonary hypertension.;Secondary Objective: The study will be extended also to patients with distal CTEPH because: - These patients present, beside proximal vessels obstruction, with distal lesion involving small and medium size pulmonary arteries similar to other form of severe pulmonary hypertension. - Furthermore an open uncontrolled study suggest beneficial hemodynamic effect after epoprostenol , sildenafil and bosentan therapy.;Primary end point(s): Primary endpoints will be: - Improvement of functional capacity compared to the basal conditions and to the period of monotherapy evaluated through distance 6 minutes walking test. - Improvement of the quality of life (WHOQOL-BRIEF questionnaire)

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026