Back to resultsEffect of Tadalafil in Chronic Obstructive Lung Disease Patients Suffering From Secondary Pulmonary Hypertension
Primary Purpose
Chronic Obstructive Lung Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Tadalafil
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Lung Disease
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Chronic obstructive lung disease
Exclusion Criteria
- Patients with asthma
Sites / Locations
- Herlev University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tadalafil treatment 40 mg
Arm Description
Outcomes
Primary Outcome Measures
Change in 6 min. walking test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00506701
Brief Title
Effect of Tadalafil in Chronic Obstructive Lung Disease Patients Suffering From Secondary Pulmonary Hypertension
Official Title
Pilot Study to Investigate the Effect of Tadalafil on Secondary Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Withdrawn
Why Stopped
due to lack of finance
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Lung Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tadalafil treatment 40 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Other Intervention Name(s)
PDE5 inhibitor
Intervention Description
40 mg tablet
Primary Outcome Measure Information:
Title
Change in 6 min. walking test
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Chronic obstructive lung disease
Exclusion Criteria
Patients with asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars C Laursen, MD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev University Hospital
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Effect of Tadalafil in Chronic Obstructive Lung Disease Patients Suffering From Secondary Pulmonary Hypertension
We'll reach out to this number within 24 hrs