- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00328523
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
February 7, 2022 updated by: Organon and Co
Ezetimibe Together With Any Statin Cholesterol Enhancement
In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl>=1.15
g/l) to compare the efficacy and the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient motivation on diet or physical activities or both).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1496
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations).
Exclusion Criteria:
- pregnant or breast feeding women
- Lipid-lowering agents including hmg-coa reductase inhibitors other than the current statin, fish oils, cholestyramin, niacin (>200 mg/day) and fibrates taken within the 3 months preceding visit 1.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).
|
Secondary Outcome Measures
Outcome Measure |
---|
Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (ACTUAL)
January 1, 2006
Study Completion (ACTUAL)
January 1, 2006
Study Registration Dates
First Submitted
May 19, 2006
First Submitted That Met QC Criteria
May 19, 2006
First Posted (ESTIMATE)
May 22, 2006
Study Record Updates
Last Update Posted (ACTUAL)
February 18, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0653-060
- 2006_024
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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