Primary HypercholesterolemiaPhase 2NCT00941603

Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)

A Phase 2 study testing SCH 900271 15mg and SCH 900271 in people with Primary Hypercholesterolemia and Mixed Hyperlipidemia, 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Primary Hypercholesterolemia, Mixed Hyperlipidemia
What is being tested?: SCH 900271 15mg and SCH 900271
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 619 participants
Where: No sites listed yet
Study dates: 29 Jun 2009to 22 Feb 2010
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

Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides [TG])
must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent

Who cannot join

The participant will be excluded from entry if ANY of the criteria listed below are met:
use of any investigational drug within 30 days of study entry
female of childbearing potential or lactating
postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
homozygous familial hypercholesterolemia
congestive heart failure New York Heart Association (NYHA) Class III or IV

Show all 22Show fewer

uncontrolled hypertension on or off therapy
cardiac arrhythmia requiring medication
clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study
gastrointestinal ulcer within 3 months of study entry
history of coagulopathy
history of gout
known active or chronic hepatic or biliary disease.
known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
body mass index >40 kg/m^2
taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 [COX-2] inhibitors are allowed)
taking more than 100 mg aspirin per day
being treated with corticosteroids (oral, intramuscular, or intravascular)
more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation

About this study

Official title: A Phase 2 Randomized, Double-Blind, Dose-Response Efficacy and Safety Study of SCH 900271 Compared to Placebo in Subjects With Primary Hypercholesterolemia (Familial and Nonfamilial) or Mixed Hyperlipidemia

The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The safety of SCH 900271 in this participant population will also be evaluated.

Conditions: Primary Hypercholesterolemia, Mixed Hyperlipidemia
Being tested: SCH 900271 15mg, SCH 900271, Placebo
Medical subject headings: Hyperlipoproteinemia Type II

What participants receive

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

SCH 900271 15mgDrug
oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks
SCH 900271Drug
oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
SCH 900271Drug
oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
SCH 900271Drug
oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
SCH 900271Drug
oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
PlaceboDrug
oral tablets; placebo administered once daily during the 5-week single-blind placebo run-in and diet stabilization period and during the 8 week double-blind treatment period.

Study groups in NCT00941603
Study group	Role	What they receive
SCH 900271 15 mg	Experimental	Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks Receives: Drug: SCH 900271 15mg
SCH 900271 10 mg	Experimental	Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks Receives: Drug: SCH 900271
SCH 900271 5 mg	Experimental	Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks Receives: Drug: SCH 900271
SCH 900271 2.5 mg	Experimental	Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks Receives: Drug: SCH 900271
SCH 900271 1 mg	Experimental	Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks Receives: Drug: SCH 900271
Placebo	Placebo comparator	Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Direct LDL-C at Week 8
The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.
Measured: Baseline and Week 8

Secondary outcomes (1)

Change From Baseline in Direct Non-HDL-C at Week 8
The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.
Measured: Baseline and Week 8

Timeline

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

29 Jun 200922 Feb 2010

First posted17 Jul 2009 (estimated)
Study start29 Jun 2009
Primary completion22 Feb 2010
Study completion22 Feb 2010

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 Primary 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 619 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00941603
Sponsor's protocol ID: P05675
Other IDs: MK-8271-004
Status last verified: Aug 2018
First submitted: 16 Jul 2009
Last updated: 25 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

All Primary Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Randomized, Double-Blind, Dose-Response Efficacy and Safety Study of SCH 900271 Compared to Placebo in Subjects With Primary Hypercholesterolemia (Familial and Nonfamilial) or Mixed Hyperlipidemia
ClinicalTrials.gov ID: NCT00941603
Acronym / sponsor ID: P05675
Conditions: Primary Hypercholesterolemia, Mixed Hyperlipidemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 619 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 29 Jun 2009 (actual)
Primary completion: 22 Feb 2010 (actual)
Study completion: 22 Feb 2010 (actual)
First posted: 17 Jul 2009 (estimated)
Results: Posted 12 Apr 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
SCH 900271 15 mg	Experimental	Drug: SCH 900271 15mgParticipants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
SCH 900271 10 mg	Experimental	Drug: SCH 900271Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
SCH 900271 5 mg	Experimental	Drug: SCH 900271Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
SCH 900271 2.5 mg	Experimental	Drug: SCH 900271Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
SCH 900271 1 mg	Experimental	Drug: SCH 900271Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
Placebo	Placebo comparator	Drug: PlaceboParticipants receive two placebo tablets once daily in the morning with water in a fasted state for 8 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)

Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides [TG])
must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent

Key exclusion criteria (22 listed)

use of any investigational drug within 30 days of study entry
female of childbearing potential or lactating
postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
homozygous familial hypercholesterolemia
congestive heart failure New York Heart Association (NYHA) Class III or IV

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
SCH 900271 15mgoral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks	Drug	SCH 900271 15 mg
SCH 900271oral tablets; SCH 900271 10 mg taken once daily for 8 weeks	Drug	SCH 900271 10 mg
SCH 900271oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks	Drug	SCH 900271 5 mg
SCH 900271oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks	Drug	SCH 900271 2.5 mg
SCH 900271oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks	Drug	SCH 900271 1 mg
Placebooral tablets; placebo administered once daily during the 5-week single-blind placebo run-in and diet stabilization period and during the 8 week double-blind treatment period.	Drug	Placebo

Primary outcome

Change From Baseline in Direct LDL-C at Week 8
Time frame: Baseline and Week 8
The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.

1 secondary outcome

Change From Baseline in Direct Non-HDL-C at Week 8
Time frame: Baseline and Week 8

Results and safety

Results posted to the registry on 12 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SCH 900271 15 mg	104	93
SCH 900271 10 mg	105	89
SCH 900271 5 mg	104	99
SCH 900271 2.5 mg	104	100
SCH 900271 1 mg	105	101
Placebo	97	94

Primary outcome: Change From Baseline in Direct LDL-C at Week 8

Time frame: Baseline and Week 8. Least squares mean (Standard Error). Unit: Percent change

Measure	SCH 900271 15 mg n = 102	SCH 900271 10 mg n = 105	SCH 900271 5 mg n = 103	SCH 900271 2.5 mg n = 101	SCH 900271 1 mg n = 105	Placebo n = 96
Value	-2.0 (1.3)	-1.5 (1.3)	-4.2 (1.3)	0.2 (1.3)	1.2 (1.3)	1.5 (1.4)

SCH 900271 15 mg vs Placebo: Difference in percent: -3.5 (95% CI -7.2 to 0.2), p = 0.06, ANOVA
SCH 900271 10 mg vs Placebo: Difference in percent: -3.1 (95% CI -6.7 to 0.6), p = 0.10, ANOVA
SCH 900271 5 mg vs Placebo: Difference in percent: -5.7 (95% CI -9.4 to -2.0), p <0.01, ANOVA

Population analysed: Intent-to-treat population defined as all participants who receive randomized treatment assignment, and have a baseline and at least one post-baseline LDL-C determination.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to approximately 96 days (including 30 days following last dose for serious adverse events). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SCH 900271 15 mg	4 of 103 (3.9%)	41 of 103 (39.8%)	Not reported
SCH 900271 10 mg	1 of 105 (1%)	41 of 105 (39%)	Not reported
SCH 900271 5 mg	3 of 104 (2.9%)	19 of 104 (18.3%)	Not reported
SCH 900271 2.5 mg	0 of 104 (0%)	8 of 104 (7.7%)	Not reported
SCH 900271 1 mg	0 of 105 (0%)	14 of 105 (13.3%)	Not reported
Placebo	0 of 97 (0%)	5 of 97 (5.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Primary 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
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

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 SCH 900271 15mg and SCH 900271 in people with Primary Hypercholesterolemia and Mixed Hyperlipidemia, 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 22 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 25 Sep 2018. 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 12 Apr 2016). 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?

Change From Baseline in Direct LDL-C at Week 8 (time frame: Baseline and Week 8). 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 NCT00941603.

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 25 Sep 2018.