Sildenafil Treatment of COPD associated Pulmonary Hypertension - Sildenafil for PH in COPD

Phase 1

• Conditions: Pulmonary hypertension in patients with chronic obstructive lung disease (COPD); MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD; MedDRA version: 9.1Level: LLTClassification code 10037400Term: Pulmonary hypertension

• Registration Number: EUCTR2008-002237-73-DK
• Lead Sponsor: Dept. of Pharmacology, Aarhus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-09
• Last Update Posted: 12 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

A diagnosis of COPD-associated pulmonary hypertension by right heart catheterization.

Stable COPD

Age > 18

Able to understand and read danish

Secure anticonception if fertile woman

In stable treatment if treated with alfa-blockers

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Reumatological disease compromising walkning ability.
Age > 80 years

FEV1 < 25 % of predicted.

Allergy to components in viagra or placebotablets.

Treatment with nitrates or aminophyllamines.

Severe liver insufficiency.
Hypotension: bloodpressure < 90/50 mmHg

Drop in blood pressure > 30/20 mm Hg or drop in peripheral saturation > 5% in relation to intake of first dose of trial medication.

Decreased sight on one eye do to non-arteritis anterior ischaemic opticusneuropathy.

Recent stroke or heart attack

Certain rare inherited eye diseases (such as retinitis pigmentosa).

Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified