Back to resultsEfficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension
Primary Purpose
Primary and Secondary Pulmonary Hypertension
Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
type-5 phosphodiesterase Inhibitor (Sildenafil)
Sponsored by
About this trial
This is an interventional treatment trial for Primary and Secondary Pulmonary Hypertension focused on measuring pulmonary arterial hypertension, type-5 phosphodiesterase Inhibitors, Sildenafil
Eligibility Criteria
Inclusion Criteria:Patients with primary and secondary pulmonary arterial hypertension - Exclusion Criteria:Unstable patients or patients with allergy to sildenafil
Sites / Locations
- Ping-Hung Kuo
Outcomes
Primary Outcome Measures
mean pulmonary artery pressure
6 min walking distance
WHO functional status
PaO2
Secondary Outcome Measures
cardiac output
VO2max
Full Information
NCT ID
NCT00155714
First Posted
September 9, 2005
Last Updated
March 15, 2010
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00155714
Brief Title
Efficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension
Official Title
Clinical Efficacy of Type-5 Phosphodiesterase Inhibitors (Sildenafil and Vadenafil) in Primary and Secondary Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Withdrawn
Why Stopped
We can't obtained the test drug (Vadenafil) from Bayer. They decided not to carry out this trail in Taiwan. Therefore this trail has never been started.
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief Summary
The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension
Detailed Description
Patients with primary and secondary pulmonary hypertension will be recruited and admitted to the ICUs of the National Taiwan University Hospital. Each patient will undergo Swan-Ganz catheterization and hemodynamic monitoring during administration of sildenafil. Efficacy of inhaled NO and Iloprost will also be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary and Secondary Pulmonary Hypertension
Keywords
pulmonary arterial hypertension, type-5 phosphodiesterase Inhibitors, Sildenafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
type-5 phosphodiesterase Inhibitor (Sildenafil)
Primary Outcome Measure Information:
Title
mean pulmonary artery pressure
Title
6 min walking distance
Title
WHO functional status
Title
PaO2
Secondary Outcome Measure Information:
Title
cardiac output
Title
VO2max
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Patients with primary and secondary pulmonary arterial hypertension
-
Exclusion Criteria:Unstable patients or patients with allergy to sildenafil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Hung Kuo, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ping-Hung Kuo
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension
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