Study of Extended Release Niacin/Laropiprant on Lipids (0... | NCT00479388

ID	Type	Description	Link
2007_521

Study of Extended Release Niacin/Laropiprant on Lipids (0... | NCT00479388 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.	Drug: niacin (+) laropiprant
2	Active Comparator	Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.	Drug: Comparator: simvastatin Drug: Comparator: atorvastatin calcium

Name	Type	Description	Arm Group Labels	Other Names
Comparator: simvastatin	Drug	simvastatin (20mg to 40mg) for 12 weeks.	2

Outcomes Module

Measure	Description	Time Frame
Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12		Baseline and 12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12		Baseline and 12 Weeks
Percent Change From Baseline in Triglycerides at Week 12		Baseline and 12 Weeks

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20518948	Result	Shah S, Ceska R, Gil-Extremera B, Paolini JF, Giezek H, Vandormael K, Mao A, McCrary Sisk C, Maccubbin D. Efficacy and safety of extended-release niacin/laropiprant plus statin vs. doubling the dose of statin in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract. 2010 May;64(6):727-38. doi: 10.1111/j.1742-1241.2010.02370.x.
22500948

Arm/Group Information

ID	Title	Description
FG000	ER Niacin/Laropiprant + Run-in Statin	One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
FG001	Run-in Statin Dose Doubled	Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000606 subjects FG001610 subjects
COMPLETED		FG000474 subjects FG001537 subjects
NOT COMPLETED		FG000132 subjects FG00173 subjects

Type	Comment	Reasons
Adverse Event		FG00090 subjects FG00145 subjects
Lost to Follow-up		FG0000 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	ER Niacin/Laropiprant + Run-in Statin	One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
BG001	Run-in Statin Dose Doubled

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12

Full Analysis Set

Posted

Least Squares Mean

95% Confidence Interval

Percent

Baseline and 12 Weeks

ID	Title	Description
OG000	ER Niacin/Laropiprant + Run-in Statin	One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
OG001	Run-in Statin Dose Doubled	Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ER Niacin/Laropiprant + Run-in Statin	One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 11.0	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Senior Vice President, Global Clinical Development	Merck Sharp & Dohme Corp	1-800-672-6372

Intervention Browse Module

ID	Term
D019821	Simvastatin
D009525	Niacin
C518174	MK-0524
D000069059	Atorvastatin

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Coronary Heart Disease Risk Category by Goal

Number

Participants

Title

Denominators

Categories

Low Risk at Goal

Title	Measurements
	BG00027 BG00126 BG00253

Low Risk Not at Goal

Title	Measurements
	BG00016 BG00114 BG00230

Multiple Risk at Goal

Title	Measurements
	BG00091 BG00182 BG002173

Multiple Risk Not at Goal

Title	Measurements
	BG00092 BG00171 BG002163

High Risk at Goal

Title	Measurements
	BG000143 BG001155 BG002298

High Risk Not at Goal

Title	Measurements
	BG000237 BG001262 BG002499

Lipid Modification Type/Dose at Run-in

Number

participants

Title

Denominators

Categories

Simvastatin 10 mg

Title	Measurements
	BG000218 BG001233 BG002451

Simvastatin 20 mg

Title	Measurements
	BG000259 BG001268 BG002527

Atorvastatin 10 mg

Title	Measurements
	BG000129 BG001109 BG002238

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 OG001		Repeated measures analysis	Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline LDL-C-by-time and concomitant statin group-by-time interaction.	0.006		Median Difference (Final Values)	-4.5	Standard Error of the Mean	1.6		95	-7.7	-1.3				No	Superiority or Other

Secondary

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12

Full Analysis Set

Posted

Least Squares Mean

95% Confidence Interval

Percent

Baseline and 12 Weeks

ID	Title	Description
OG000	ER Niacin/Laropiprant + Run-in Statin	One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
OG001	Run-in Statin Dose Doubled	Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.

Units	Counts
Participants	OG000572 OG001595

Title

Denominators

Categories

Title	Measurements
	OG00015.8(13.8 to 17.8) OG0010.2(-1.1 to 1.4)

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 OG001		Repeated measures analysis	Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline HDL-C-by-time and concomitant statin group-by-time interaction.	<=0.001		Mean Difference (Final Values)	15.6	Standard Error of the Mean	1.2		95	13.4	17.9				No	Superiority or Other

Secondary

Percent Change From Baseline in Triglycerides at Week 12

Full Analysis Set With at Least one Post-Titration Visit Measurement

Posted

Median

95% Confidence Interval

Percent

Baseline and 12 Weeks

ID	Title	Description
OG000	ER Niacin/Laropiprant + Run-in Statin	One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
OG001	Run-in Statin Dose Doubled	Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.

Units	Counts
Participants	OG000515 OG001571

Title

Denominators

Categories

Title	Measurements
	OG000-17.6(-21.0 to -14.2) OG001-4.0(-7.2 to -0.9)

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 OG001		Repeated measures analysis	ANCOVA model based on Tukey's normalized ranks with term for treatment, gender, concomitant statin group and Tukey's normal score of baseline.	<=0.001		Mean Difference (Final Values)	-15.4				95	-19.2	-11.7				No	Superiority or Other