Hypercholerolemia Clinical Trial
Official title:
A Double-Blind, Randomized, Multicenter, Active-Comparative, 12-Week Study to Assess the Efficacy and Safety of the Drug in Conjunction With Another Drug in Korean Patients With Primary Hypercholesterolemia
| Verified date | February 2022 |
| Source | Organon and Co |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period. Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes approximately 18 weeks for an individual patient to complete including post-visit at week 14.
| Status | Completed |
| Enrollment | 136 |
| Est. completion date | December 2003 |
| Est. primary completion date | October 2003 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Korean males or females at least 18 years of age with hypercholesterolemia |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Organon and Co |
Bae JW, Kim HS, Lee SC, Han KH, Jeon ES. The safety and efficacy of ezetimibe and simvastatin combination therapy in Korean patients with primary hypercholesterolemia. Korean J Med. 2005;68(5):487-497 [in Korean].
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | LDL-C | |||
| Secondary | TC, TG, HDL-C, Apolipoprotein A1, Apolipoprotein B, lipoprotein (a), LDL-C:HDL-C ratio, TC:HDL-C ratio |