Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900... | NCT00941603

ID	Type	Description	Link
MK-8271-004	Other Identifier	Merck protocol number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	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	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	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	Drug: SCH 900271

Name	Type	Description	Arm Group Labels	Other Names
SCH 900271 15mg	Drug	oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks	SCH 900271 15 mg

Measure	Description	Time Frame
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.	Baseline and Week 8

Measure	Description	Time Frame
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.	Baseline and Week 8

Eligibility Module

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

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

ID	Type	URL	Comment
	CSR Synopsis	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	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
BG003	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
BG004	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
BG005	Placebo	Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
BG006	Total	Total of all reporting groups

Units	Counts
Participants	BG000104 BG001105 BG002104 BG003104 BG004105 BG00597 BG006619

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline and Week 8

ID	Title	Description
OG000	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
OG001	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
OG002	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
OG003	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
OG004	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
OG005	Placebo	Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks

Units	Counts
Participants	OG000102 OG001105 OG002103 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-2.0± 1.3 OG001-1.5± 1.3 OG002-4.2± 1.3 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG005		ANOVA	Least-square (LS) means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.	0.06		Difference in percent	-3.5			2-Sided	95	-7.2	0.2					Superiority or Other
OG001 OG005		ANOVA

Secondary

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.

Intent-to-treat population defined as all participants who receive randomized treatment assignment and have a baseline and at least one post-baseline non-HDL-C determination.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline and Week 8

ID	Title	Description
OG000	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
OG001	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
OG002	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
OG003	SCH 900271 2.5 mg

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	4	103	41	103
EG001	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	1	105	41	105
EG002	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	3	104	19	104
EG003	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	0	104	8	104
EG004	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	0	105	14	105
EG005	Placebo	Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks	0	97	5	97

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial flutter	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected104 at risk EG0030 events0 affected104 at risk EG0040 events0 affected105 at risk EG0050 events0 affected97 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected104 at risk EG003
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected104 at risk EG003
Tenderness	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected104 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected104 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected104 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected104 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected104 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected104 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected104 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected104 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected104 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected103 at risk EG0011 events1 affected105 at risk EG0020 events0 affected104 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected104 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0010 events0 affected105 at risk EG0020 events0 affected104 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected103 at risk EG0010 events0 affected105 at risk EG0021 events1 affected104 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0016 events6 affected105 at risk EG0022 events2 affected104 at risk EG0030 events0 affected104 at risk EG0040 events0 affected105 at risk EG0050 events0 affected97 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected103 at risk EG0017 events6 affected105 at risk EG0021 events1 affected104 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00020 events18 affected103 at risk EG00124 events21 affected105 at risk EG0029 events8 affected104 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00018 events17 affected103 at risk EG00121 events18 affected105 at risk EG0027 events7 affected104 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected103 at risk EG0018 events7 affected105 at risk EG0022 events2 affected104 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0006 events6 affected103 at risk EG0016 events5 affected105 at risk EG0027 events6 affected104 at risk EG003
Flushing	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG00019 events18 affected103 at risk EG00114 events14 affected105 at risk EG0023 events3 affected104 at risk EG003

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006951	Hyperlipoproteinemias
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases