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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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12 September 2016 |
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Main ID: |
NCT02034071 |
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Date of registration:
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08/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome
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Scientific title:
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A Dose Titration Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal Extension |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02034071 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Virginia Kimonis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Irvine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children. adolescents and young adults with genetically confirmed Prader-Willi
syndrome
- Ages at = 10 years and = 22 years
- Generally healthy as documented by the medical history, physical examination, vital
sign assessments, 12-lead electrocardiogram (ECG), and clinical laboratory
assessments
- BMI exceeds the 95th percentile of the age specific BMI value on the CDC BMI charts
- Fasting glucose = 126 mg/dL
- HbA1c = 6.5 %
Exclusion Criteria:
- Administration of investigational drugs within 1 month prior to Screening Visit
- Anticipated requirement for use of prohibited medications
- History of allergic reaction or significant intolerance to: diazoxide, thiazides or
sulfonamides
- Anticipate transitions in their care from family home to group home or other similar
potentially disruptive changes
- Congestive heart failure or known compromised cardiac reserve
- Any other clinically significant endocrine, cardiovascular, pulmonary, neurological,
psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological
disease interfering with the assessments of the investigational drug, according to
the Investigator
Age minimum:
10 Years
Age maximum:
22 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prader-Willi Syndrome
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Intervention(s)
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Drug: DCCR
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Drug: Placebo
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Primary Outcome(s)
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Resting energy expenditure
[Time Frame: Change from Day 69 through Day 97]
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Hyperphagia using hyperphagia questionnaire
[Time Frame: Change from Day 69 through Day 97]
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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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