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Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.

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. Identifier: NCT00705588
Recruitment Status : Unknown
Verified May 2008 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 26, 2008
Last Update Posted : June 26, 2008
Information provided by:
Rabin Medical Center

Brief Summary:

Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil).

Although these drugs are known to be effective alone, little is known about combining them together in various combinations.

In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with pulmonary arterial hypertension who currently are receiving only a prostanoid drug.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Tadalafil Drug: Vardenafil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2008
Estimated Primary Completion Date : January 2010

Arm Intervention/treatment
Experimental: 1
Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).
Drug: Tadalafil
Orally, titrated to maximum 20mg od
Other Name: Cialis

Experimental: 2
Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)
Drug: Vardenafil
Orally, titrated to 10 mg bid
Other Name: Levitra

Primary Outcome Measures :
  1. Six minute walking distance [ Time Frame: 12 weeks ]
  2. Level of pro-NT BNP [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Echo-derived parameters [ Time Frame: 12 weeks ]
  2. Cardiopulmonary exercise test [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): Mean PAP >25mmHg at rest or >30mmHg with exercise, by a PCWP< 15mmHg and by PVR >3 Wood Units.
  • Currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).
  • Willing and able to participate in all study follow-up procedures.
  • New York Heart Association (NYHA) Class II-IV.
  • Six minute walking distance between 100-450 meters at the baseline assessment.
  • Women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
  • Patients with congenital heart disease are eligible for inclusion.

Exclusion Criteria:

  • Functional Class NYHA Class I.
  • PAH due to chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (VC or FEV1 < 60% of predicted) or chronic hypoxia.
  • Acute intercurrent illness requiring hospital admission in the month proceeding screening.
  • Any non-PAH medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.
  • Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
  • Concomitant therapy with drugs known to interact adversely with the study drug.
  • Chronic renal failure - creatinine clearance <50ml/min as calculated with the Cockcroft equation.
  • Current participation in another clinical trial.
  • Pregnancy or planned pregnancy during the study period.

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 identifier (NCT number): NCT00705588

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Contact: Mordechai R Kramer, MD 972-3-937-7221

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Pulmonary Institute, Rabin Medical Center Not yet recruiting
Petach Tikva, Israel, 49100
Sub-Investigator: Benjamin D Fox, BM BCh MRCP         
Sponsors and Collaborators
Rabin Medical Center
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Principal Investigator: Mordechai R Kramer, MD Rabin Medical Center

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Responsible Party: Prof MR Kramer, Rabin Medical Center Identifier: NCT00705588     History of Changes
Other Study ID Numbers: RMC084936CTIL
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: June 26, 2008
Last Verified: May 2008
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents