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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: |
NCT00499642 |
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Date of registration:
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10/07/2007 |
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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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Study Evaluating the Effect of Lecozotan SR on the QTc Interval
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Scientific title:
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A Single-Dose, Double-Blind, Crossover, Placebo- and Moxifloxacin (Open-Label)-Controlled Study of the Effects of Lecozotan SR on Cardiac Repolarization in Healthy Adult Subjects |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00499642 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For France: infomedfrance@wyeth.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women and men aged 18 to 55 years inclusive.
- Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital signs, and 12-lead
electrocardiogram (ECG).
Exclusion Criteria:
- History of any clinically important drug allergy.
- Positive findings of urine drug screen (eg, amphetamines, barbiturates,
benzodiazepines, cannabinoids, cocaine, and opiates).
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Healthy
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Intervention(s)
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Drug: Lecozotan SR
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Drug: Moxifloxacin
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Primary Outcome(s)
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To assess the effect of drug administration on QTc interval.
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Secondary ID(s)
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3098B1-133
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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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