Trial · NCT01524289
Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)
NCT01524289, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020). Trials, record NCT01524289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01524289
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)
- NCT number
- NCT01524289
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 306 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hyperlipoproteinemia Type II, Hypercholesterolemia, Familial
- Interventions
- Anacetrapib, Placebo
- First posted
- 2012-02-01
- Last updated
- 2019-10-14
- Other registries' IDs
- eudract:2011-004525-27
- Results first posted
- 2019-08-28
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) - Treatment Phase | Baseline and Week 52 | LDL-C levels were measured at baseline and week 52 (or at discontinuation) using a beta quantification method. The Treatment Phase was the period from the date of the participant's first dose of study treatment (randomization visit, Visit 3) to the participant's last visit on treatment (discontinuation visit or Visit 8 \[Week 52\]). |
| Primary | Percentage of Participants With Any Adverse Event - Treatment Phase | Up to 52 weeks | An adverse event (AE) or experience was any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a study treatment, whether or not considered related to the use of the study treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment is also an AE. The percentage of participants with any adverse event during the treatment phase is presented. |
| Primary | Percentage of Participants With Any Treatment-Related Adverse Event - Treatment Phase | Up to 52 weeks | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment was also an AE. AEs reported by the investigator as definitely, probably or possibly related to study treatment were considered treatment-related. The percentage of participants with any treatment-related adverse event during the treatment phase is presented. |
| Primary | Percentage of Participants With Any Serious Adverse Event - Treatment Phase | Up to 52 weeks | A serious adverse experience (SAE) was any adverse event that occurred at any dose that resulted in death or was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, or was a congenital anomaly/birth defect. The percentage of participants with any serious adverse event during the treatment phase is presented. |
| Primary | Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event - Treatment Phase | Up to 52 weeks | An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which was temporally associated with the use of the study drug was also an AE. The percentage of participants who discontinued study treatment due to an AE during the treatment phase is presented. |
| Primary | Percentage of Participants With Changes in Systolic Blood Pressure (SBP) >= 10 mm Hg | Up to 52 weeks | Participants had SBP assessed at baseline and throughout the 52-week treatment period. Percentage of participants who had a SBP reading that was \>= 10 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented. |
| Primary | Percentage of Participants With Changes in SBP >= 15 mm Hg | Up to 52 weeks | Participants had SBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a SBP reading that was \>= 15 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented. |
| Primary | Percentage of Participants With Changes in Diastolic Blood Pressure (DBP) >= 10 mm Hg | Up to 52 weeks | Participants had DBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a DBP reading that was \>= 10 mm Hg higher than their baseline DBP for any assessment performed during the treatment phase is presented. |
| Primary | Percentage of Participants With Sodium Levels > Upper Limit of Normal (ULN) | Up to 52 weeks | Participants had sodium levels assessed throughout the 52-week treatment period. The percentage of participants who had any sodium level that was greater than the ULN of 145 mEq/L during the treatment phase is presented. |
| Primary | Percentage of Participants With Chloride Levels > ULN | Up to 52 weeks | Participants had chloride levels assessed throughout the 52-week treatment period. The percentage of participants who had any chloride level that was \> the ULN of 110 mEq/L during the treatment phase is presented. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) - Treatment Phase | Baseline and Week 52 | The full analysis set (FAS) population consisted of all randomized participants who received at least one dose of study treatment, had at least one post randomization observation for the analysis endpoint subsequent to at least one dose of study treatment and had baseline data for those analyses that require baseline data. | Percent Change | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants With Any Adverse Event - Treatment Phase | Up to 52 weeks | The all participants as treated (APaT) population consisted of all randomized participants who received at least one dose of study treatment. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Any Treatment-Related Adverse Event - Treatment Phase | Up to 52 weeks | The APaT population consisted of all randomized participants who received at least one dose of study treatment. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Any Serious Adverse Event - Treatment Phase | Up to 52 weeks | The APaT population consisted of all randomized participants who received at least one dose of study treatment. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event - Treatment Phase | Up to 52 weeks | The APaT population consists of all randomized participants who received at least one dose of study treatment. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Changes in Systolic Blood Pressure (SBP) >= 10 mm Hg | Up to 52 weeks | The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Changes in SBP >= 15 mm Hg | Up to 52 weeks | The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Changes in Diastolic Blood Pressure (DBP) >= 10 mm Hg | Up to 52 weeks | The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Sodium Levels > Upper Limit of Normal (ULN) | Up to 52 weeks | The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Chloride Levels > ULN | Up to 52 weeks | The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria. | Percentage of Participants | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) - Treatment Phase | Anacetrapib 100 mg | -36.0 | 95% Confidence Interval -39.5 to -32.5 | Percent Change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) - Treatment Phase | Placebo | 3.7 | 95% Confidence Interval -1.2 to 8.6 | Percent Change | |
| Percentage of Participants With Any Adverse Event - Treatment Phase | Anacetrapib 100 mg | 76.4 | Percentage of Participants | ||
| Percentage of Participants With Any Adverse Event - Treatment Phase | Placebo | 78.4 | Percentage of Participants | ||
| Percentage of Participants With Any Treatment-Related Adverse Event - Treatment Phase | Anacetrapib 100 mg | 18.2 | Percentage of Participants | ||
| Percentage of Participants With Any Treatment-Related Adverse Event - Treatment Phase | Placebo | 13.7 | Percentage of Participants | ||
| Percentage of Participants With Any Serious Adverse Event - Treatment Phase | Anacetrapib 100 mg | 8.9 | Percentage of Participants | ||
| Percentage of Participants With Any Serious Adverse Event - Treatment Phase | Placebo | 9.8 | Percentage of Participants | ||
| Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event - Treatment Phase | Anacetrapib 100 mg | 5.9 | Percentage of Participants | ||
| Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event - Treatment Phase | Placebo | 4.9 | Percentage of Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anacetrapib 100 mg | 204 | |
| Overall Study | STARTED | Placebo | 102 | |
| Overall Study | Treated | Anacetrapib 100 mg | 203 | |
| Overall Study | Treated | Placebo | 102 | |
| Overall Study | COMPLETED | Anacetrapib 100 mg | 174 | |
| Overall Study | COMPLETED | Placebo | 88 | |
| Overall Study | NOT COMPLETED | Anacetrapib 100 mg | 30 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events172
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 | Diarrhoea | Gastrointestinal disorders | Anacetrapib 100 mg - Treatment Phase | 16 | 203 | 19 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo - Treatment Phase | 9 | 102 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Anacetrapib 100 mg - Reversal Phase | 0 | 196 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo - Reversal Phase | 0 | 95 | 0 |
| other | Gastroenteritis | Infections and infestations | Anacetrapib 100 mg - Treatment Phase | 2 | 203 | 2 |
| other | Gastroenteritis | Infections and infestations | Placebo - Treatment Phase | 6 | 102 | 7 |
| other | Gastroenteritis | Infections and infestations | Anacetrapib 100 mg - Reversal Phase | 0 | 196 | 0 |
| other | Gastroenteritis | Infections and infestations | Placebo - Reversal Phase | 0 | 95 | 0 |
| other | Influenza | Infections and infestations | Anacetrapib 100 mg - Treatment Phase | 20 | 203 | 22 |
| other | Influenza | Infections and infestations | Placebo - Treatment Phase | 11 | 102 | 11 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anacetrapib 100 mg - Treatment Phase | 0 | 203 |
| Total, all-cause mortality | Placebo - Treatment Phase | 0 | 102 |
| Total, all-cause mortality | Anacetrapib 100 mg - Reversal Phase | 0 | 196 |
| Total, all-cause mortality | Placebo - Reversal Phase | 0 | 95 |
| Total, other adverse events | Anacetrapib 100 mg - Treatment Phase | 87 | 203 |
| Total, other adverse events | Placebo - Treatment Phase | 41 | 102 |
| Total, other adverse events | Anacetrapib 100 mg - Reversal Phase | 0 | 196 |
| Total, other adverse events | Placebo - Reversal Phase | 0 | 95 |
| Total, serious adverse events | Anacetrapib 100 mg - Treatment Phase | 18 | 203 |
| Total, serious adverse events | Placebo - Treatment Phase | 10 | 102 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25743173 | BACKGROUND |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01524289
GET https://conductscience.org/api/trials/v1/NCT01524289/registered?page=2