HypercholesterolemiaPhase 2NCT00687271

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

A Phase 2 study testing MK-6213 and Atorvastatin calcium in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: MK-6213 and Atorvastatin calcium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 334 participants
Where: No sites listed yet
Study dates: 14 Jun 2008to 8 Jan 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

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.

Conditions: Hypercholesterolemia
Being tested: MK-6213, Atorvastatin calcium, Placebo for MK-6312 160 mg, Placebo for Atorvastatin 20 mg
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-6213Drug
MK-6213 160 mg for 4 weeks.
Atorvastatin calciumDrug
Also called atorvastatin, LIPITOR ®
atorvastatin calcium 20mg for 4 weeks.
Placebo for MK-6312 160 mgDrug
Placebo for Atorvastatin 20 mgDrug

Study groups in NCT00687271
Study group	Role	What they receive
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 Receives: Drug: MK-6213; Drug: 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 Receives: Drug: Atorvastatin calcium; Drug: 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 Receives: Drug: MK-6213; Drug: 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 Receives: Drug: Placebo for MK-6312 160 mg; Drug: Placebo for Atorvastatin 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline (predose) and Week 4

Secondary outcomes (7)

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
Measured: 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
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.
Measured: up to 4 weeks
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.
Measured: Baseline (predose) and Week 4
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.
Measured: Baseline (predose) and Week 4
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.
Measured: Baseline (predose) and Week 4
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.
Measured: Baseline (predose) and Week 4
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.
Measured: Baseline (predose) and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 20088 Jan 2009

First posted30 May 2008 (estimated)
Study start14 Jun 2008
Primary completion8 Jan 2009
Study completion8 Jan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00687271
Sponsor's protocol ID: 6213-006
Other IDs: 2007_514, 2007-003684-41, MK-6314-006
Status last verified: Jan 2019
First submitted: 27 May 2008
Last updated: 14 Jan 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00687271
Acronym / sponsor ID: 6213-006
Conditions: Hypercholesterolemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 14 Jun 2008 (actual)
Primary completion: 8 Jan 2009 (actual)
Study completion: 8 Jan 2009 (actual)
First posted: 30 May 2008 (estimated)
Results: Posted 1 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
MK-6213 160 mg + Atorvastatin 20 mg	Experimental	Drug: MK-6213, Drug: Atorvastatin calcium1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks
Atorvastatin 20 mg	Active comparator	Drug: Atorvastatin calcium, Drug: Placebo for MK-6312 160 mg1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks
MK-6213 160 mg	Experimental	Drug: MK-6213, Drug: Placebo for Atorvastatin 20 mg1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
Placebo	Placebo comparator	Drug: Placebo for MK-6312 160 mg, Drug: Placebo for Atorvastatin 20 mg1 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

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-6213MK-6213 160 mg for 4 weeks.	Drug	MK-6213 160 mg, MK-6213 160 mg + Atorvastatin 20 mg
Atorvastatin calciumAlso: atorvastatin, LIPITOR ®atorvastatin calcium 20mg for 4 weeks.	Drug	Atorvastatin 20 mg, MK-6213 160 mg + Atorvastatin 20 mg
Placebo for MK-6312 160 mg	Drug	Atorvastatin 20 mg, Placebo
Placebo for Atorvastatin 20 mg	Drug	MK-6213 160 mg, Placebo

Primary outcome

Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline (predose) and Week 4
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.

7 secondary outcomes

Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
Time frame: 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
Time frame: up to 4 weeks
Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Time frame: Baseline (predose) and Week 4
Percentage Change From Baseline in Apolipoprotein B (ApoB)
Time frame: Baseline (predose) and Week 4
Percentage Change From Baseline in Total Cholesterol (TC)
Time frame: Baseline (predose) and Week 4
Percentage Change From Baseline in HDL-C
Time frame: Baseline (predose) and Week 4
Percentage Change From Baseline in TG
Time frame: Baseline (predose) and Week 4

Results and safety

Results posted to the registry on 1 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-6213 160 mg + Atorvastatin 20 mg	94	91
Atorvastatin 20 mg	96	90
MK-6213 160 mg	96	91
Placebo	48	48

Primary outcome: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

Time frame: Baseline (predose) and Week 4. Least squares mean (95% Confidence Interval). Unit: Percentage Change

Measure	MK-6213 160 mg + Atorvastatin 20 mg n = 92	Atorvastatin 20 mg n = 89	MK-6213 160 mg n = 92	Placebo n = 47
Value	-50.7 (-53.8 to -47.5)	-40.6 (-43.8 to -37.4)	-13.3 (-16.5 to -0.1)	4.6 (0.2 to 9.1)

MK-6213 160 mg + Atorvastatin 20 mg vs Atorvastatin 20 mg: Difference in Percentage Change: -10.0 (95% CI -14.6 to -5.5), Longitudinal Data Analysis (LDA) model
MK-6213 160 mg vs Placebo: Difference in Percentage Change: -17.9 (95% CI -23.4 to -12.5), LDA model

Population analysed: All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 2 weeks post last dose (up to 6 weeks total). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-6213 160 mg + Atorvastatin 20 mg	0 of 94 (0%)	3 of 94 (3.2%)	0 of 94
Atorvastatin 20 mg	0 of 95 (0%)	5 of 95 (5.3%)	0 of 95
MK-6213 160 mg	0 of 96 (0%)	5 of 96 (5.2%)	0 of 96
Placebo	0 of 48 (0%)	2 of 48 (4.2%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-6213 and Atorvastatin calcium in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) (time frame: Baseline (predose) and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00687271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.