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Efficacy of Lapaquistat Acetate and Simvastatin in Subjects With Primary Dyslipidemia.

NCT00256178 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2012-05-24

No results posted yet for this study

Summary

The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with simvastatin on cholesterol levels in subjects with primary dyslipidemia

Conditions

Interventions

DRUG

Lapaquistat acetate and simvastatin

Lapaquistat acetate 50 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.

DRUG

Lapaquistat acetate and simvastatin

Lapaquistat acetate 100 mg, tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.

DRUG

Simvastatin

Lapaquistat acetate placebo-matching tablets, orally, once daily and stable simvastatin therapy for up to 24 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Czechia
  • Estonia
  • Finland
  • Germany
  • Poland
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

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 NCT00256178 on ClinicalTrials.gov