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This study has been withdrawn prior to enrollment.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:
Herlev Hospital
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00506701
First received: July 23, 2007
Last updated: February 25, 2010
Last verified: July 2007
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 23, 2007 | ||||
| Last Updated Date | February 25, 2010 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in 6 min. walking test [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Change in 6 min. walking test [ Time Frame: 6 months ] | ||||
| Change History | Complete list of historical versions of study NCT00506701 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Tadalafil in Chronic Obstructive Lung Disease Patients Suffering From Secondary Pulmonary Hypertension | ||||
| Official Title ICMJE | Pilot Study to Investigate the Effect of Tadalafil on Secondary Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Obstructive Lung Disease | ||||
| Intervention ICMJE | Drug: Tadalafil
40 mg tablet
Other Name: PDE5 inhibitor |
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| Study Arm (s) | Experimental: Tadalafil treatment 40 mg
Intervention: Drug: Tadalafil |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | February 2010 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 45 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00506701 | ||||
| Other Study ID Numbers ICMJE | 25 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lars C. Laursen, Herlev Hospital | ||||
| Study Sponsor ICMJE | Herlev Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Herlev Hospital | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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