Lipid Efficacy/Tolerability Study (0524A-020) | NCT00269204

Studies
Lipid Efficacy/Tolerability Study (0524A-020)

NCT00269204

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Jul 27, 2015Estimated

Enrollment

1,620Actual

Phase

Phase 3

Conditions

Primary Hypercholesterolaemia
Mixed Hyperlipidaemia

Interventions

niacin (+) laropiprant
ER-niacin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Dec 21, 2005

First Submission Date that Met QC Criteria

Dec 21, 2005

First Posted Date

Dec 23, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2015

Last Update Posted Date

Jul 27, 2015Estimated

Description Module

Brief Summary

A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,620Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
niacin (+) laropiprant	Drug	Duration of Treatment - 24 weeks		MK0524A
ER-niacin	Drug	Duration of Treatment - 24 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reductions of LDL-C concentrations at 24 weeks and better tolerability		at 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Elevations in HDL-C concentrations at 24 weeks		at 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 to 85 years of age with Primary Hypercholesterolemia or Mixed Hyperlipidemia with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD).
Have medical conditions considered to be CHD equivalent).
LDL-C below 130 mg/dL for patients with multiple risk factors.
LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17087947	Background	Baron JA, Sandler RS, Bresalier RS, Quan H, Riddell R, Lanas A, Bolognese JA, Oxenius B, Horgan K, Loftus S, Morton DG; APPROVe Trial Investigators. A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. Gastroenterology. 2006 Dec;131(6):1674-82. doi: 10.1053/j.gastro.2006.08.079. Epub 2006 Sep 1.
19166443

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
D009525	Niacin
C518174	MK-0524

ID	Term
D009539	Nicotinic Acids
D000147	Acids, Heterocyclic
D006571	Heterocyclic Compounds
D011725	Pyridines

ID	Type	Description	Link
MK0524A-020
2005_095