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Sponsored by: |
Rabin Medical Center |
Information provided by: | Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT00705588 |
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 | Intervention | Phase |
Pulmonary Arterial Hypertension |
Drug: Tadalafil Drug: Vardenafil |
Phase IV |
Genetics Home Reference related topics: | pulmonary arterial hypertension |
MedlinePlus related topics: | High Blood Pressure Pulmonary Hypertension |
ChemIDplus related topics: | Vardenafil Tadalafil |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Patients treated with epoprostenol (Flolan) will be given tadalafil (Cialis).
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Drug: Tadalafil
Orally, titrated to maximum 20mg od
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2: Experimental
Patients receiving iloprost (Ventavis) will receive vardenafil (Levitra)
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Drug: Vardenafil
Orally, titrated to 10 mg bid
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mordechai R Kramer, MD | 972-3-937-7221 | kremerm@clalit.org.il |
Israel | |||||
Pulmonary Institute, Rabin Medical Center | Not yet recruiting | ||||
Petach Tikva, Israel, 49100 | |||||
Sub-Investigator: Benjamin D Fox, BM BCh MRCP |
Rabin Medical Center |
Principal Investigator: | Mordechai R Kramer, MD | Rabin Medical Center |
Responsible Party: | Rabin Medical Center ( Prof MR Kramer ) |
Study ID Numbers: | RMC084936CTIL |
First Received: | June 25, 2008 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00705588 |
Health Authority: | Israel: Ministry of Health |
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