Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
August 27, 2018 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
619
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SCH 900271 15 mg
Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks
|
|
Experimental: SCH 900271 10 mg
Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
|
|
Experimental: SCH 900271 5 mg
Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
|
|
Experimental: SCH 900271 2.5 mg
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
|
oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
|
|
Experimental: SCH 900271 1 mg
Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
|
|
Placebo Comparator: Placebo
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Direct Non-HDL-C at Week 8
Time Frame: Baseline and 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.
|
Baseline and Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2009
Primary Completion (Actual)
February 22, 2010
Study Completion (Actual)
February 22, 2010
Study Registration Dates
First Submitted
July 16, 2009
First Submitted That Met QC Criteria
July 16, 2009
First Posted (Estimate)
July 17, 2009
Study Record Updates
Last Update Posted (Actual)
September 25, 2018
Last Update Submitted That Met QC Criteria
August 27, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05675
- MK-8271-004 (Other Identifier: Merck protocol number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.