NCT00398294

Brief Summary

To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

November 9, 2006

Last Update Submit

August 12, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks

Interventions

MK0733, simvastatin / Duration of Treatment: 12 WeeksDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patient, \>18 years of age
  • Patients with hypercholesterolemia who meet the following lipid criteria:
  • primary cholesterolemia: total cholesterol\>=240 mg/dl or ldl-c \>= 160 mg/dl
  • secondary cholesterolemia (patients with cad, dm): ldl-c\>=130 mg/dl
  • The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study

You may not qualify if:

  • Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmias, unstable angina pectoris
  • Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1
  • Uncontrolled hypertension with systolic blood pressure \> 160 mmhg or diastolic \> 100 mmhg at visit 1.
  • Unstable diabetes (hba1c \>9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merck Sharp & Dohme (I.A.) Corp.

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

SimvastatinDuration of Therapy

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2006

First Posted

November 10, 2006

Study Start

May 1, 2005

Primary Completion

April 4, 2006

Study Completion

April 4, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02

Locations

TW(1)