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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506701
First Posted: July 25, 2007
Last Update Posted: March 18, 2015
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.
Information provided by:
Herlev Hospital
  Purpose
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: 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

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 ]

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.
  Eligibility

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
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Chronic obstructive lung disease

Exclusion Criteria

  • Patients with asthma
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00506701


Locations
Denmark
Herlev University Hospital
Herlev, Denmark, DK-2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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
First Submitted: July 23, 2007
First Posted: July 25, 2007
Last Update Posted: March 18, 2015
Last Verified: July 2007

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