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Sponsored by: |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
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Information provided by: | Sanjay Gandhi Postgraduate Institute of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00626665 |
In this double-blinded, placebo-controlled, fixed-dose, study patients will be randomly assigned to take placebo or 20 mg tadalafil thrice weekly for 6 weeks. After 6 weeks a wash out period of 2 week will be observed and then the two groups will be switched over to receive the other drug. We planned a priori to include 20 patients. The concomitant medication for treatment of rheumatic disease remained unchanged during the whole study. Patient will undergo clinical and lab evaluation for organ damage for kidney and lungs. ECHO heart will be done at base line to assess the PAH and LV function and repeated at the end of the study. Blood pressure will be recorded at each visit. A physician unaware of the treatment group will record skin score and appearance of new cutaneous ulcers. The primary outcome variables will be frequency and duration of Raynauds attacks, evolution of trophic digital lesions and change in flow mediated dilatation of the brachial artery. Flow mediated dilatation of the brachial artery will be done at baseline 6 and 12 weeks.
Condition | Intervention |
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Raynaud Disease |
Drug: Tadalafil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma |
Enrollment: | 25 |
Study Start Date: | December 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded if they have:
Responsible Party: | Sanjay Gandhi Postgraduate Institute of Medical Sciences ( Vikas Agarwal, PI ) |
Study ID Numbers: | A-15;PGI/DM/EC/40/7/11/07 |
Study First Received: | February 21, 2008 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00626665 |
Health Authority: | India: Institutional Review Board |
Raynaud disease Scleroderma |
Peripheral Vascular Diseases Raynaud Disease Tadalafil Vascular Diseases |
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