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

Primary Purpose

Primary Hypercholesterolemia, Mixed Hyperlipidemia

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SCH 900271 15mg

SCH 900271

Placebo

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

SCH 900271 15 mg

SCH 900271 10 mg

SCH 900271 5 mg

SCH 900271 2.5 mg

SCH 900271 1 mg

Placebo

Arm Description

Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

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

Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00941603

First Posted

July 16, 2009

Last Updated

August 27, 2018

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00941603

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

June 29, 2009 (Actual)

Primary Completion Date

February 22, 2010 (Actual)

Study Completion Date

February 22, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hypercholesterolemia, Mixed Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

619 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SCH 900271 15 mg

Arm Type

Experimental

Arm Description

Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Arm Title

SCH 900271 10 mg

Arm Type

Experimental

Arm Description

Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Arm Title

SCH 900271 5 mg

Arm Type

Experimental

Arm Description

Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Arm Title

SCH 900271 2.5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

SCH 900271 1 mg

Arm Type

Experimental

Arm Description

Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks

Intervention Type

Drug

Intervention Name(s)

SCH 900271 15mg

Intervention Description

oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

SCH 900271

Intervention Description

oral tablets; SCH 900271 10 mg taken once daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

SCH 900271

Intervention Description

oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

SCH 900271

Intervention Description

oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

SCH 900271

Intervention Description

oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change From Baseline in Direct LDL-C at Week 8

Description

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.

Time Frame

Baseline and Week 8

Secondary Outcome Measure Information:

Title

Change From Baseline in Direct Non-HDL-C at Week 8

Description

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.

Time Frame

Baseline and Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis

Available IPD/Information URL

http://www.merck.com/clinical-trials/study.html?id=P05675&kw=P05675&tab=access

Learn more about this trial

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

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