NCT00687271

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
15 days until next milestone

Study Start

First participant enrolled

June 14, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2009

Completed
9.8 years until next milestone

Results Posted

Study results publicly available

November 1, 2018

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

May 27, 2008

Results QC Date

October 2, 2018

Last Update Submit

January 11, 2019

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Percentage of Participants Who Experience at Least 1 Adverse Event (AE)

    Up to 14 days post last dose of study drug (up to 6 weeks)

  • Percentage of Participants That Had Study Drug Discontinued Due to an AE

    up to 4 weeks

  • Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

    Baseline (predose) and Week 4

  • Percentage Change From Baseline in Apolipoprotein B (ApoB)

    Baseline (predose) and Week 4

  • Percentage Change From Baseline in Total Cholesterol (TC)

    Baseline (predose) and Week 4

  • +2 more secondary outcomes

Study Arms (4)

MK-6213 160 mg + Atorvastatin 20 mg

EXPERIMENTAL

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

Drug: MK-6213Drug: Atorvastatin calcium

Atorvastatin 20 mg

ACTIVE COMPARATOR

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

Drug: Atorvastatin calciumDrug: Placebo for MK-6312 160 mg

MK-6213 160 mg

EXPERIMENTAL

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

Drug: MK-6213Drug: Placebo for Atorvastatin 20 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo for MK-6312 160 mgDrug: Placebo for Atorvastatin 20 mg

Interventions

MK-6213DRUG

MK-6213 160 mg for 4 weeks.

MK-6213 160 mgMK-6213 160 mg + Atorvastatin 20 mg
Atorvastatin calciumDRUG

atorvastatin calcium 20mg for 4 weeks.

Also known as: atorvastatin, LIPITOR ®
Atorvastatin 20 mgMK-6213 160 mg + Atorvastatin 20 mg
Placebo for MK-6312 160 mgDRUG
Atorvastatin 20 mgPlacebo
Placebo for Atorvastatin 20 mgDRUG
MK-6213 160 mgPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

June 14, 2008

Primary Completion

January 8, 2009

Study Completion

January 8, 2009

Last Updated

January 14, 2019

Results First Posted

November 1, 2018

Record last verified: 2019-01