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NCT00506701 Clinical Trial

Effect of Tadalafil in Chronic Obstructive Lung Disease Patients Suffering From Secondary Pulmonary Hypertension

Chronic Obstructive Lung Disease Clinical Trial

Official title:
Pilot Study to Investigate the Effect of Tadalafil on Secondary Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00506701
Other study ID # 25
Secondary ID
Status Withdrawn
Phase N/A
First received July 23, 2007
Last updated March 17, 2015
Start date February 2008
Est. completion date February 2010

Study information
Verified date July 2007
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

Tadalafil may lower the pulmonary artery pressure in patients with Chronic Obstructive Lung Disease and secondary pulmonary hypertension and thereby improve patients quality of life.

Description:

Twenty outpatients with Chronic Obstructive Lung Disease (COPD) and secondary pulmonary hypertension are treated in a cross-over design with Tadalafil or placebo for 4 weeks. Primary effect parameter is 6 min. walking test.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 85 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of Chronic obstructive lung disease

Exclusion Criteria

- Patients with asthma

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tadalafil
40 mg tablet

Locations
Country Name City State
Denmark Herlev University Hospital Herlev

Sponsors (1)
Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in 6 min. walking test 6 months No
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