Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||January 2010|
U.S. FDA Resources
Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).
Orally, titrated to maximum 20mg od
Other Name: Cialis
Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)
Orally, titrated to 10 mg bid
Other Name: Levitra
- Six minute walking distance [ Time Frame: 12 weeks ]
- Level of pro-NT BNP [ Time Frame: 12 weeks ]
- Echo-derived parameters [ Time Frame: 12 weeks ]
- Cardiopulmonary exercise test [ Time Frame: 12 weeks ]
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): NCT00705588
|Contact: Mordechai R Kramer, MDfirstname.lastname@example.org|
|Pulmonary Institute, Rabin Medical Center||Not yet recruiting|
|Petach Tikva, Israel, 49100|
|Sub-Investigator: Benjamin D Fox, BM BCh MRCP|
|Principal Investigator:||Mordechai R Kramer, MD||Rabin Medical Center|