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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00001965 |
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Date of registration:
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18/01/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cyclosporine A to Treat Hypertrophic Cardiomyopathy (HCM)
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Scientific title:
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Double Blind Placebo Controlled Study of Cyclosporin A in Patients With Left Ventricular Hypertrophy Caused by Sarcomeric Gene Mutations |
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Date of first enrolment:
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December 1999 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001965 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Patients of either gender, aged 18-75 years, with HCM caused by sarcomeric gene mutations
determined by existing protocols.
LV wall thickness of greater than or equal to 20 mm measured in any LV segment by MRI.
Severe symptoms refractory to medical treatment (New York Heart Association functional
class III or IV).
No LV outflow tract obstruction at rest greater than 30 mm Hg as determined by cardiac
catheterization.
No coronary artery disease (greater than 50% arterial luminal narrowing of a major
epicardial vessel).
No chronic atrial fibrillation.
No bleeding disorder (PTT greater than 35 sec, pro time greater than 14 sec, platelet
count less than 154 k/mm(3).
No anemia (Hb less than 12.7 g/dl in males and less than 11.0 g/dl in females).
No renal impairment (serum creatinine greater than 1.3 mg/dl).
No hepatitis B or C; nor unexplained abnormal LFTs.
No inability to estimate LV wall thickness.
No positive urine pregnancy test.
No pregnant or lactating female patients.
No concurrent use of immunosuppressives or steroids.
No diabetes mellitus.
No history of malignancy other than skin tumors (squamous and basal cell) in the last 5
years.
No condition that excludes the patient from undergoing an MRI test.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiomyopathy, Hypertrophic
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Heart Hypertrophy
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Intervention(s)
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Drug: Cyclosporine A
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Secondary ID(s)
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000034
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00-H-0034
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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