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Efficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension

This study has been withdrawn prior to enrollment.
(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.)
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155714
First received: September 9, 2005
Last updated: March 15, 2010
Last verified: January 2010
History of Changes
  Purpose

The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension


Condition Intervention
Primary and Secondary Pulmonary Hypertension
 Drug: type-5 phosphodiesterase Inhibitor (Sildenafil)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Type-5 Phosphodiesterase Inhibitors (Sildenafil and Vadenafil) in Primary and Secondary Pulmonary Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • mean pulmonary artery pressure
  • 6 min walking distance
  • WHO functional status
  • PaO2

Secondary Outcome Measures:
  • cardiac output
  • VO2max

Estimated Enrollment: 20
Study Start Date: November 2002
Estimated Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Patients with primary and secondary pulmonary arterial hypertension

-

Exclusion Criteria:Unstable patients or patients with allergy to sildenafil

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00155714

Locations
Taiwan
Ping-Hung Kuo
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ping-Hung Kuo, MD National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00155714     History of Changes
Other Study ID Numbers: 9100017321
Study First Received: September 9, 2005
Last Updated: March 15, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
pulmonary arterial hypertension
type-5 phosphodiesterase Inhibitors
Sildenafil

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Phosphodiesterase Inhibitors
Sildenafil
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Phosphodiesterase 5 Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013