Hypercholesterolemia, DyslipidemiaPhase 1NCT00935259

Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)

A Phase 1 study testing Simvastatin in people with Hypercholesterolemia, Dyslipidemia, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 30 to 70 years, men only
Conditions the study is for: Hypercholesterolemia, Dyslipidemia
What is being tested?: Simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: No sites listed yet
Study dates: Jul 2009to Oct 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia

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.

Conditions: Hypercholesterolemia, Dyslipidemia
Being tested: Simvastatin, Placebo
Keywords: Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor
Medical subject headings: Hypercholesterolemia, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SimvastatinDrug
Also called Zocor
40 mg once daily for 2 weeks
PlaceboDrug
Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks

Study groups in NCT00935259
Study group	Role	What they receive
Simvastatin 40 mg first, then placebo	Experimental	Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks Receives: Drug: Simvastatin; Drug: 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 Receives: Drug: Simvastatin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 weeks

Secondary outcomes (4)

Fasting Blood Lipidomic Levels After 2 Weeks of Treatment
Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.
The mean reported was an adjusted mean.
Measured: 2 weeks
Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level
Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio [dose = 162 g/m^2]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion.
The mean reported was an adjusted mean (defined in first outcome measure).
Measured: 2 weeks
Blood Linoleic Acid Levels
Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.
Measured: 2 weeks
Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo
Change in fasting delta 5 desaturase enzyme activity compared to placebo. Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Oct 2009

First posted8 Jul 2009 (estimated)
Study startJul 2009
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypercholesterolemia, DyslipidemiaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00935259
Sponsor's protocol ID: 0000-140
Other IDs: 2009_609
Status last verified: Oct 2015
First submitted: 7 Jul 2009
Last updated: 8 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21417623

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia, Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia
ClinicalTrials.gov ID: NCT00935259
Acronym / sponsor ID: 0000-140
Conditions: Hypercholesterolemia, Dyslipidemia
Keywords: Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 8 Jul 2009 (estimated)
Results: Posted 20 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Simvastatin 40 mg first, then placebo	Experimental	Drug: Simvastatin, Drug: PlaceboSimvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks
Placebo first, then simvastatin 40 mg once daily	Placebo comparator	Drug: Simvastatin, Drug: PlaceboPlacebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks

Who may qualify

Ages: 30 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SimvastatinAlso: Zocor40 mg once daily for 2 weeks	Drug	Placebo first, then simvastatin 40 mg once daily, Simvastatin 40 mg first, then placebo
PlaceboPlacebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks	Drug	Placebo first, then simvastatin 40 mg once daily, Simvastatin 40 mg first, then placebo

Primary outcome

Arachidonic Acid Level After 2 Weeks of Treatment
Time frame: 2 weeks
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.

4 secondary outcomes

Fasting Blood Lipidomic Levels After 2 Weeks of Treatment
Time frame: 2 weeks
Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level
Time frame: 2 weeks
Blood Linoleic Acid Levels
Time frame: 2 weeks
Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo
Time frame: 2 weeks

Results and safety

Results posted to the registry on 20 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simvastatin 40 mg, Then Placebo	16	15
Placebo First, Then Simvastatin 40 mg	15	14

Primary outcome: Arachidonic Acid Level After 2 Weeks of Treatment

Time frame: 2 weeks. Mean (Standard Deviation). Unit: nmol

Measure	Simvastatin 40 mg n = 27	Placebo n = 29
Value	259.1 (89.1)	269.6 (85.2)

Simvastatin 40 mg vs Placebo: Mean Difference (Final Values): -10.4, p = 0.455, Mixed Models Analysis

Population analysed: Only participants with complete arachidonic acid data were included.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simvastatin	0 of 30 (0%)	1 of 30 (3.3%)	Not reported
Placebo	0 of 30 (0%)	2 of 30 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21417623Chen 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.

Related trials for Hypercholesterolemia, Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Simvastatin in people with Hypercholesterolemia, Dyslipidemia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arachidonic Acid Level After 2 Weeks of Treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00935259, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.