NCT00935259

Brief Summary

The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1

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

July 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 20, 2012

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

July 7, 2009

Results QC Date

December 17, 2010

Last Update Submit

October 7, 2015

Conditions

Hypercholesterolemia, Dyslipidemia

Keywords

Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor

Outcome Measures

Primary Outcomes (1)

  • Arachidonic Acid Level After 2 Weeks of Treatment

    Arachidonic acid level (20:4n6) in the cholesterol ester lipid class. The mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term.

    2 weeks

Secondary Outcomes (4)

  • Fasting Blood Lipidomic Levels After 2 Weeks of Treatment

    2 weeks

  • Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level

    2 weeks

  • Blood Linoleic Acid Levels

    2 weeks

  • Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo

    2 weeks

Study Arms (2)

Simvastatin 40 mg first, then placebo

EXPERIMENTAL

Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks

Drug: SimvastatinDrug: Placebo

Placebo first, then simvastatin 40 mg once daily

PLACEBO COMPARATOR

Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks

Drug: SimvastatinDrug: Placebo

Interventions

SimvastatinDRUG

40 mg once daily for 2 weeks

Also known as: Zocor
Placebo first, then simvastatin 40 mg once dailySimvastatin 40 mg first, then placebo
PlaceboDRUG

Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks

Placebo first, then simvastatin 40 mg once dailySimvastatin 40 mg first, then placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is a Caucasian (including Hispanic) male
  • Participant has a maximum waist size of 40 inches
  • Participant does not currently use any lipid-altering medications
  • Participant is in good health other than the diagnosis of dyslipidemia

You may not qualify if:

  • Participant has had stomach ulcers within the last 3 months
  • Participant has had a heart attack in the last 6 months or has angina
  • Participant has chronic heart failure
  • Participant has a history of stroke, seizures, or major neurological disorder
  • Participant has a history of cancer
  • Participant has a gastrointestinal condition that affects bowel movements
  • Participant has type 1 or 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chen F, Maridakis V, O'Neill EA, Hubbard BK, Strack A, Beals C, Herman GA, Wong P. The effects of simvastatin treatment on plasma lipid-related biomarkers in men with dyslipidaemia. Biomarkers. 2011 Jun;16(4):321-33. doi: 10.3109/1354750X.2011.561367. Epub 2011 Mar 21.

    PMID: 21417623DERIVED

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemias

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 8, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 8, 2015

Results First Posted

February 20, 2012

Record last verified: 2015-10