Efficacy Study of Extended-Release Niacin/Lovastatin Vers... | NCT00345657

Studies
Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care

NCT00345657

Sponsor

In His Image

Status

Completed

Last Update Posted

Jun 28, 2006Estimated

Enrollment

100

Phase

Phase 4

Conditions

Hyperlipidemia
Mixed Hyperlipidemia
Dyslipidemia

Interventions

Niacin Extended Release/Lovastatin

Countries

United States

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

Jun 2006

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

Jul 2003

Primary Completion Date

Not provided

Completion Date

May 2004

First Submitted Date

Jun 27, 2006

First Submission Date that Met QC Criteria

Jun 27, 2006

First Posted Date

Jun 28, 2006Estimated

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

Jun 27, 2006

Last Update Posted Date

Jun 28, 2006Estimated

Name	Class
Kos Pharmaceuticals	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Detailed Description

Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
Niacin Extended Release/Lovastatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lipid parameter change at 3 and 6 months
Percent of patients achieving ATP III LDL goals at 3 and 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years old with CAD or risk factors for CAD
under standard care at Family Medical Care of Tulsa
not at LDL goal per ATP III guidelines

Exclusion Criteria:

pregnancy/lactating
liver disease
allergies to statin or niacin
active peptic ulcer disease
previous treatment with combination therapy for dyslipidemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason A Logan, MD	In His Image Family Medicine Residency	Principal Investigator
Edward Rylander, MD	In His Image Family Medicine Residency	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Family Medical Care of Tulsa		Tulsa	Oklahoma	74136	United States

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias
D006938	Hyperlipoproteinemia Type II
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D008052	Lipid Metabolism, Inborn Errors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008148	Lovastatin

Ancestor Terms

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided