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

NCT ID: NCT00687271

Last Updated: 2019-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-14

Study Completion Date

2009-01-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-6213 160 mg + Atorvastatin 20 mg

1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks

Group Type EXPERIMENTAL

MK-6213

Intervention Type DRUG

MK-6213 160 mg for 4 weeks.

Atorvastatin calcium

Intervention Type DRUG

atorvastatin calcium 20mg for 4 weeks.

Atorvastatin 20 mg

1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Atorvastatin calcium

Intervention Type DRUG

atorvastatin calcium 20mg for 4 weeks.

Placebo for MK-6312 160 mg

Intervention Type DRUG

MK-6213 160 mg

1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks

Group Type EXPERIMENTAL

MK-6213

Intervention Type DRUG

MK-6213 160 mg for 4 weeks.

Placebo for Atorvastatin 20 mg

Intervention Type DRUG

Placebo

1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo for MK-6312 160 mg

Intervention Type DRUG

Placebo for Atorvastatin 20 mg

Intervention Type DRUG

Interventions

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MK-6213

MK-6213 160 mg for 4 weeks.

Intervention Type DRUG

Atorvastatin calcium

atorvastatin calcium 20mg for 4 weeks.

Intervention Type DRUG

Placebo for MK-6312 160 mg

Intervention Type DRUG

Placebo for Atorvastatin 20 mg

Intervention Type DRUG

Other Intervention Names

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atorvastatin LIPITOR ®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2007_514

Identifier Type: OTHER

Identifier Source: secondary_id

2007-003684-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-6314-006

Identifier Type: OTHER

Identifier Source: secondary_id

6213-006

Identifier Type: -

Identifier Source: org_study_id

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