The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00718952
• Date of registration: 18/07/2008
• Prospective Registration: No
• Primary sponsor: Tongji University
• Public title: The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension EVALUATION
• Scientific title: Multi-centre, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Treatment of Pulmonary Arterial Hypertension With Vardenafil in China
• Date of first enrolment: July 2008
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00718952
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Zhi-Cheng Jing, MD
• Affiliation: Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects aged 12-65.

- Confirmed idiopathic pulmonary hypertension, connective tissue disease associated
pulmonary hypertension, congenital heart disease(with Eisenmenger syndrome)
associated pulmonary hypertension.

- Baseline 6-minutes walking distance 150m-550m.

- WHO pulmonary hypertension function II-III with non-responder to calcium channel
blockers.

- Documented written informed consent.

Exclusion Criteria:

- The other types of pulmonary hypertension.

- Subjects who refuse to subscribe written informed consents or can't cooperate with
the trial well.

- Subjects with serious acute or chronic disease involved liver, kidney, and brain or
have to use potent CYP3A4-inhibitor or nitrate to treat the underlying diseases.

- Subjects who are currently treated with sildenafil for PAH or taking sildenafil or
tadalafil.

- Other contraindications in package insert.



Age minimum: 12 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: Placebo

Drug: Vardenafil

Primary Outcome(s)

The change in exercise capacity, as measured by the total distance walked in six minutes [Time Frame: at week 12 and week 24]

Secondary Outcome(s)

Time from randomization to clinical worsening(defined as death, transplantation,hospitalization for PAH and worse right heart failure,acute heart failure,or vardenafil allergy,or worsening leading to discontinuation,need for epoprostenol or bosentan) [Time Frame: From baseline to week 24]

The change in the Borg dyspnea index(a measure of perceived breathlessness on a scale of 0 to 10, with higher values indicating more severe dyspnea) [Time Frame: at week 12 and week 24]

The change in World Health Organization (WHO) functional classification of pulmonary arterial hypertension (an adaptation of the New York Heart Association classification) [Time Frame: at week 12 and week 24]

The increase of Peripheral Saturation of oxygen(SPO2) [Time Frame: at week 12 and week 24]

The increase of cardiac output(CO) [Time Frame: at week 12 and week 24]

The reduction of mean pulmonary-artery pressure(mPAP)and pulmonary vascular resistance(PVR) [Time Frame: at week 12 and week 24]

Secondary ID(s)

EVALUATION-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors