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Safety of Lapaquistat Acetate in Subjects With Hypercholesterolemia

NCT00868127 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2012-05-24

No results posted yet for this study

Summary

The purpose of this study is to determine the long-term safety of lapaquistat acetate, once daily (QD), as monotherapy or in combination with other lipid-lowering agents in Subjects with Hypercholesterolemia.

Conditions

Interventions

DRUG

Lapaquistat acetate

Participants from 01-04-TL-475-008 Monotherapy Study: Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 48 weeks.

DRUG

Lapaquistat acetate and additional lipid-lowering therapy

Participants from 01-04-TL-475-009 Atorvastatin Add-on Study: Lapaquistat acetate 100 mg, tablets, orally, once daily and current Atorvastatin therapy for up to 4 weeks. Then, Lapaquistat 100 mg, tablets, orally, once daily and dose adjustment of Atorvastatin OR additional companion lipid-lowering therapy as needed for target LDL-C for up to 42 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-07-31
Completion
2007-07-31

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868127 on ClinicalTrials.gov