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Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension

NCT ID: NCT00730067

Last Updated: 2012-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms.

In this study 32 patients with increased pulmonary blood pressure due to COPD will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension.

Our hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.

Detailed Description

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Conditions

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COPD Pulmonary Hypertension

Keywords

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COPD Pulmonary hypertension Sildenafil NT-pro BNP apelin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Sildenafil treatment

Group Type EXPERIMENTAL

sildenafil

Intervention Type DRUG

Sildenafil 50 mg three times daily

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.

Interventions

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sildenafil

Sildenafil 50 mg three times daily

Intervention Type DRUG

placebo

tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.

Intervention Type DRUG

Other Intervention Names

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Viagra

Eligibility Criteria

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Inclusion Criteria

* A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization.
* A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
* Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
* Age \> 18
* Informed written consent.
* Reliable anticonception for fertile women.

Exclusion Criteria

* Rheumatic disease limiting walking capacity.
* Exacerbation in COPD during the study.
* Age\>80 years
* FEV1 \< 25 % of predicted.
* Allergy towards contents of sildenafil or placebo tablets.
* Fall in blood pressure of \> 30 mmHg systolic or \>20 mmHg diastolic after intake of the first dose of trial medication.
* Fall in peripheral saturation of \> 5% after intake of the first dose of trial medication.
* Treatment with nitrous vasodilators or aminophyllamines.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Charlotte Andersen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ole Hilberg, MDSC

Role: PRINCIPAL_INVESTIGATOR

Århus Sygehus

Jens Erik Nielsen-Kudsk, MDSC

Role: PRINCIPAL_INVESTIGATOR

Skejby Sygehus

Locations

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Department of Pulmonary Diseases, Århus Sygehus

Aarhus, , Denmark

Site Status

Department of Cardiology, Skejby sygehus

Århus N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2008-002237-73

Identifier Type: -

Identifier Source: org_study_id