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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00506701
Recruitment Status : Withdrawn (due to lack of finance)
First Posted : July 25, 2007
Last Update Posted : March 18, 2015
Information provided by:
Herlev Hospital

Brief 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.

Condition or disease Intervention/treatment
Chronic Obstructive Lung Disease Drug: Tadalafil

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study to Investigate the Effect of Tadalafil on Secondary Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease
Study Start Date : February 2008
Primary Completion Date : February 2010
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tadalafil treatment 40 mg Drug: Tadalafil
40 mg tablet
Other Name: PDE5 inhibitor

Primary Outcome Measures :
  1. Change in 6 min. walking test [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Chronic obstructive lung disease

Exclusion Criteria

  • Patients with asthma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00506701

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

Responsible Party: Lars C. Laursen, Herlev Hospital Identifier: NCT00506701     History of Changes
Other Study ID Numbers: 25
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: July 2007

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