A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)

Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy, and Tolerability of MK-6213 Co-Administered With Atorvastatin in Patients With Primary Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687271
• Other study ID #: 6213-006
• Secondary ID: 2007_5142007-003
• Status: Completed
• Phase: Phase 2
• Start date: June 14, 2008
• Est. completion date: January 8, 2009

Study information

• Verified date: January 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: January 8, 2009
• Est. primary completion date: January 8, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 to 75 years of age at the time of the study with high cholesterol

• Can have diabetes mellitus but is not currently on lipid lowering therapy

• Have a stable weight for >6 weeks

Exclusion Criteria:

• Has significant cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease

• history of mental instability or drug/alcohol abuse within the past 5 years

• Pregnant or nursing; human immunodeficiency virus (HIV) positive; history of cancer within the past 5 years or participation in an investigational trial within the last 30 days

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• MK-6213
MK-6213 160 mg for 4 weeks.
• Atorvastatin calcium
atorvastatin calcium 20mg for 4 weeks.
• Placebo for MK-6312 160 mg

• Placebo for Atorvastatin 20 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)	Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized.	Baseline (predose) and Week 4
Secondary	Percentage of Participants Who Experience at Least 1 Adverse Event (AE)	An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized	Up to 14 days post last dose of study drug (up to 6 weeks)
Secondary	Percentage of Participants That Had Study Drug Discontinued Due to an AE	An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.	up to 4 weeks
Secondary	Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	Blood collected at baseline (predose) and after 4 weeks of treatment to determine non-HDL-C levels. The percentage change from baseline at Week 4 was summarized.	Baseline (predose) and Week 4
Secondary	Percentage Change From Baseline in Apolipoprotein B (ApoB)	Blood collected at baseline (predose) and after 4 weeks of treatment to determine ApoB levels. The percentage change from baseline at Week 4 was summarized.	Baseline (predose) and Week 4
Secondary	Percentage Change From Baseline in Total Cholesterol (TC)	Blood collected at baseline (predose) and after 4 weeks of treatment to determine TC levels. The percentage change from baseline at Week 4 was summarized.	Baseline (predose) and Week 4
Secondary	Percentage Change From Baseline in HDL-C	Blood collected at baseline (predose) and after 4 weeks of treatment to determine HDL-C levels. The percentage change from baseline at Week 4 was summarized.	Baseline (predose) and Week 4
Secondary	Percentage Change From Baseline in TG	Blood collected at baseline (predose) and after 4 weeks of treatment to determine TG levels. The percentage change from baseline at Week 4 was summarized.	Baseline (predose) and Week 4