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

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ClinicalTrials.gov Identifier: NCT00718952
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : February 12, 2010
Sponsor:
Information provided by:
Tongji University

Tracking Information
First Submitted Date  ICMJE July 18, 2008
First Posted Date  ICMJE July 21, 2008
Last Update Posted Date February 12, 2010
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
The change in exercise capacity, as measured by the total distance walked in six minutes [ Time Frame: at week 12 and week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
  • The reduction of mean pulmonary-artery pressure(mPAP)and pulmonary vascular resistance(PVR) [ Time Frame: at week 12 and week 24 ]
  • The increase of cardiac output(CO) [ 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 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension
Official Title  ICMJE Multi-centre, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Treatment of Pulmonary Arterial Hypertension With Vardenafil in China
Brief Summary The purpose of this study is to evaluate the efficacy and safety of vardenafil in the treatment of pulmonary arterial hypertension.
Detailed Description

Pulmonary arterial hypertension (PAH), defined as a mean pulmonary artery pressure ≥25 mmHg with a pulmonary capillary wedge pressure ≤15 mmHg measured by cardiac catheterization, is a disorder that may occur either in the setting of a variety of underlying medical conditions or as a disease that uniquely affects the pulmonary circulation. Irrespective of its etiologies, PAH is a serious and often progressive disorder that results in right ventricular dysfunction and impairment in activity tolerance, and may lead to right-heart failure and death. The pathogenesis of PAH is complex and incompletely understood, but includes both genetic and environmental factors that alter vascular structure and function.

In recent years, several new drugs have been developed for the treatment of pulmonary arterial hypertension (PAH), including continuous intravenous epoprostenol, inhaled iloprost, subcutaneous trepostinil, oral bosentan, and oral beraprost. In addition, there is increasing evidence for the therapeutic effectiveness of the phosphodiesterase-5 (PDE-5) inhibitor sildenafil in PAH. Phosphodiesterases are a superfamily of enzymes that inactivate cyclic adenosine monophosphate and cyclic guanosine monophosphate, the second messengers of prostacyclin and nitric oxide (NO) .The phosphodiesterases have different tissue distributions and substrate affinities. Interestingly, PDE-5 is abundantly expressed in lung tissue, thus offering as target molecule for PAH treatment concepts.

The three commercially available PDE-5 inhibitors (sildenafil, vardenafil, and tadalafil) are currently approved for the treatment of erectile dysfunction . These inhibitors are now receiving attention for their activity in the pulmonary vasculature. Sildenafil has been proved to improve the exercise capacity and pulmonary hemodynamics of PAH patients, however, there are few reports regarding the use of vardenafil or tadalafil on the pulmonary vasculature. Although sildenafil, vardenafil, and tadalafil act on the same enzyme, these drugs exhibit different pharmacokinetics and selectivity, and therefore may not be equally efficacious in the pulmonary vascular bed. As vardenafil has a more than 20-fold greater potency than sildenafil for inhibiting purified PDE-5, we assume that it will show more favorable clinical and side-effect profiles in treating PAH.

This is a prospective, randomized, placebo-controlled, pilot study to evaluate the efficacy and safety of vardenafil in the treatment of pulmonary arterial hypertension.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE
  • Drug: Vardenafil
    vardenafil tablet 5mg once-daily orally in the first 4 weeks while 5mg twice-daily orally in the following 8 weeks.
    Other Name: Levitra
  • Drug: Placebo
    Placebo tablet 5mg once-daily orally in the first 4 weeks while 5mg twice-daily orally in the following 8 weeks.
  • Drug: Vardenafil
    Patients in all the 2 arms will take vardenafil tablet 5mg twice-daily orally from week 13 to week 24(open-label).
    Other Name: Levitra
Study Arms  ICMJE
  • Experimental: A
    Patients in group A will receive vardenafil in double-blinded treatment period.
    Interventions:
    • Drug: Vardenafil
    • Drug: Vardenafil
  • Placebo Comparator: B
    Patients in group A will receive placebo in double-blinded treatment period.
    Interventions:
    • Drug: Placebo
    • Drug: Vardenafil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 18, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00718952
Other Study ID Numbers  ICMJE EVALUATION-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Zhi-Cheng JING, Shanghai Pulmonary Hospital, Tongji University,Shanghai, China
Study Sponsor  ICMJE Tongji University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhi-Cheng Jing, MD Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China
PRS Account Tongji University
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP