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Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
This study has been completed.
Sponsored by: Sanjay Gandhi Postgraduate Institute of Medical Sciences
Information provided by: Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00626665
  Purpose

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
Raynaud Disease
Drug: Tadalafil

MedlinePlus related topics: Raynaud's Disease
Drug Information available for: Tadalafil
U.S. FDA Resources
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

Further study details as provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:

Primary Outcome Measures:
  • The primary outcome variables will be frequency and duration of Raynaud's attacks, evolution of trophic digital lesions [ Time Frame: 6 weeeks and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in flow mediated dilatation of the brachial artery [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: Tadalafil
    Tablets, 20 mg, alternate days, 6 weeks
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects between the ages of 18 years and 60 years will be selected for the study if they have a clinical diagnosis of Raynaud's phenomenon secondary to systemic sclerosis (scleroderma). Raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor, as well as a history of at least 4 attacks per week during two pre-trial period even with treatment with other vasodilators. The diagnosis of scleroderma is defined by the American College of Rheumatology (ACR) criteria or by the presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias).

Exclusion Criteria:

Patients will be excluded if they have:

  • Symptomatic orthostatic hypotension
  • Evidence of current malignancy
  • History of sympathectomy
  • Upper extremity deep vein thrombosis or lymphedema within 3 months
  • Recent surgical procedure requiring general anesthesia
  • AMI, unstable angina, strokes and TIA within the past three months
  • Smoking
  • Use of any investigational drug within 30 days of the study sessions
  • Use of medications that might interfere with tadalafil like nitrates and alpha adrenergic blockers that have vasoactive effects, and patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole, erythromycin, itraconazole, and grapefruit juice
  • Patients taking alcohol
  • Patients with bleeding disorders
  • Significant active peptic ulceration
  • Current pregnancy
  • Current breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626665

Sponsors and Collaborators
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Investigators
Principal Investigator: Vikas Agarwal, MD, DM Sanjay Gandhi Postgraduate Institute of Medical Sciences
  More Information

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

Keywords provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:
Raynaud disease
Scleroderma

Study placed in the following topic categories:
Peripheral Vascular Diseases
Raynaud Disease
Tadalafil
Vascular Diseases

Additional relevant MeSH terms:
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009