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

This study has been withdrawn prior to enrollment.
(due to lack of finance)
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
First received: July 23, 2007
Last updated: March 17, 2015
Last verified: July 2007
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.

Condition Intervention
Chronic Obstructive Lung Disease
Drug: Tadalafil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study to Investigate the Effect of Tadalafil on Secondary Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Change in 6 min. walking test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tadalafil treatment 40 mg Drug: Tadalafil
40 mg tablet
Other Name: PDE5 inhibitor

Detailed 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.

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Chronic obstructive lung disease

Exclusion Criteria

  • Patients with asthma
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00506701

Herlev University Hospital
Herlev, Denmark, DK-2730
Sponsors and Collaborators
Herlev Hospital
Principal Investigator: Lars C Laursen, MD University of Copenhagen
  More Information

Responsible Party: Lars C. Laursen, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00506701     History of Changes
Other Study ID Numbers: 25 
Study First Received: July 23, 2007
Last Updated: March 17, 2015
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2016