Trials / Completed
CompletedNCT03882892
Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)
Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 18 Years – 86 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.
Detailed description
This study is a long-term extension study of the protocol P00692 parent study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ezetimibe | Ezetimibe 10 mg tablets |
| DRUG | Atovastatin | Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg |
| DRUG | Placebo | Placebo tablets matched to ezetimibe |
Timeline
- Start date
- 2001-02-02
- Primary completion
- 2002-08-08
- Completion
- 2002-08-08
- First posted
- 2019-03-20
- Last updated
- 2024-05-10
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03882892. Inclusion in this directory is not an endorsement.