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

Primary and Secondary Pulmonary Hypertension Clinical Trial

Official title:

Clinical Efficacy of Type-5 Phosphodiesterase Inhibitors (Sildenafil and Vadenafil) in Primary and Secondary Pulmonary Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00155714
• Other study ID #: 9100017321
• Status: Withdrawn
• Phase: N/A
• First received: September 9, 2005
• Last updated: March 15, 2010
• Start date: November 2002
• Est. completion date: May 2005

Study information

• Verified date: January 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 20
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:Patients with primary and secondary pulmonary arterial hypertension

Exclusion Criteria:Unstable patients or patients with allergy to sildenafil

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Neoplasm Metastasis
• Primary and Secondary Pulmonary Hypertension

Intervention

Drug:
• type-5 phosphodiesterase Inhibitor (Sildenafil)

Locations

Country	Name	City	State
Taiwan	Ping-Hung Kuo	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean pulmonary artery pressure
Primary	6 min walking distance
Primary	WHO functional status
Primary	PaO2
Secondary	cardiac output
Secondary	VO2max