Trial · NCT00935259
Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
NCT00935259, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2012-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED). Trials, record NCT00935259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00935259
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
- NCT number
- NCT00935259
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 31 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Interventions
- Simvastatin, Placebo
- First posted
- 2009-07-08
- Last updated
- 2015-10-08
- Results first posted
- 2012-02-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arachidonic Acid Level After 2 Weeks of Treatment | 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. |
| Secondary | Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | 2 weeks | Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo. The mean reported was an adjusted mean. |
| Secondary | Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level | 2 weeks | 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). |
| Secondary | Blood Linoleic Acid Levels | 2 weeks | Change in blood linoleic acid levels for Cholesterol Ester compared to placebo. |
| Secondary | Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo | 2 weeks | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Arachidonic Acid Level After 2 Weeks of Treatment | 2 weeks | Only participants with complete arachidonic acid data were included. | nmol | MEAN |
| SECONDARY | Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | 2 weeks | Only participants with complete blood lipidomic data were included.~For cholesterol ester 22:5n6, n=26 for the simvastatin arm and n=27 for the placebo arm. | nmol | MEAN |
| SECONDARY | Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level | 2 weeks | Only participants with complete PCSK9 data were included. | nmol | MEAN |
| SECONDARY | Blood Linoleic Acid Levels | 2 weeks | Only participants with complete blood linoleic acid data were included. | nmol | MEAN |
| SECONDARY | Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo | 2 weeks | Only participants with complete fasting delta 5 desaturase enzyme activity data were included. | ratio | MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Arachidonic Acid Level After 2 Weeks of Treatment | Simvastatin 40 mg | 259.1 | Standard Deviation 89.1 | nmol | |
| Arachidonic Acid Level After 2 Weeks of Treatment | Placebo | 269.6 | Standard Deviation 85.2 | nmol | |
| Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | Simvastatin 40 mg | Cholesterol ester lipid 16:00 | 288.9 | Standard Deviation 102.1 | nmol |
| Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | Placebo | Cholesterol ester lipid 16:00 | 345.1 | Standard Deviation 87.3 | nmol |
| Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | Simvastatin 40 mg | Cholesterol ester lipid 18:3n3 | 10.0 | Standard Deviation 4.8 | nmol |
| Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | Placebo | Cholesterol ester lipid 18:3n3 | 14.4 | Standard Deviation 6.7 | nmol |
| Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | Simvastatin 40 mg | Cholesterol ester lipid 20:3n6 | 20.9 | Standard Deviation 10.5 | nmol |
| Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | Placebo | Cholesterol ester lipid 20:3n6 | 23.5 | Standard Deviation 10.2 | nmol |
| Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | Simvastatin 40 mg | Cholesterol ester lipid 20:3n9 | 1.3 | Standard Deviation 1.1 | nmol |
| Fasting Blood Lipidomic Levels After 2 Weeks of Treatment | Placebo | Cholesterol ester lipid 20:3n9 | 1.2 | Standard Deviation 0.9 | nmol |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Simvastatin 40 mg, Then Placebo | 16 | |
| Period 1 | STARTED | Placebo First, Then Simvastatin 40 mg | 15 | |
| Period 1 | COMPLETED | Simvastatin 40 mg, Then Placebo | 15 | |
| Period 1 | COMPLETED | Placebo First, Then Simvastatin 40 mg | 14 | |
| Period 1 | NOT COMPLETED | Simvastatin 40 mg, Then Placebo | 1 | |
| Period 1 | NOT COMPLETED | Placebo First, Then Simvastatin 40 mg | 1 | |
| Period 2 | STARTED | Simvastatin 40 mg, Then Placebo | 15 | |
| Period 2 | STARTED | Placebo First, Then Simvastatin 40 mg | 14 | |
| Period 2 | COMPLETED | Simvastatin 40 mg, Then Placebo | 15 | |
| Period 2 | COMPLETED | Placebo First, Then Simvastatin 40 mg | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tension headache | Nervous system disorders | Simvastatin | 1 | 30 | 1 |
| other | Tension headache | Nervous system disorders | Placebo | 1 | 30 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Simvastatin | 0 | 30 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 30 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Simvastatin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Simvastatin | 1 | 30 |
| Total, other adverse events | Placebo | 2 | 30 |
| Total, serious adverse events | Simvastatin | 0 | 30 |
| Total, serious adverse events | Placebo | 0 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21417623 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Simvastatin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00935259
GET https://conductscience.org/api/trials/v1/NCT00935259/results?page=2