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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.
Register: ClinicalTrials.gov
Last refreshed on: 29 July 2022
Main ID:  NCT03649477
Date of registration: 24/08/2018
Prospective Registration: Yes
Primary sponsor: Levo Therapeutics, Inc.
Public title: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome CARE-PWS
Scientific title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, 8-week Clinical Study to Assess the Efficacy, Safety, and Tolerability, of Intranasal Carbetocin (LV-101) in Prader-Willi Syndrome (PWS) With Long Term Follow-Up (CARE-PWS)
Date of first enrolment: November 20, 2018
Target sample size: 130
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03649477
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Australia Canada United States
Contacts
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 17/11/2021
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT03649477
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