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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00155714
First Posted: September 12, 2005
Last Update Posted: March 16, 2010
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:
National Taiwan University Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

ClinicalTrials.gov Identifier: NCT00155714     History of Changes
Other Study ID Numbers: 9100017321
First Submitted: September 9, 2005
First Posted: September 12, 2005
Last Update Posted: March 16, 2010
Last Verified: January 2010

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

Additional relevant MeSH terms:
Hypertension
Neoplasm Metastasis
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Phosphodiesterase Inhibitors
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents