Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)

An AE or suspected adverse reaction was considered an SAE if it resulted in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All events were adjudicated by an expert committee independent of the Sponsor. The percentage of participants that experienced adjudicated SAEs of CV death, non-fatal stroke, non-fatal myocardial infarction, or unstable angina during the treatment phase is presented.

Time frame: Up to 52 weeks

Population: The APaT population consisted of all randomized participants who received at least one dose of study treatment.

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.

Time frame: Up to 52 weeks

Population: The APaT population consists of all randomized participants who received at least one dose of study treatment.

The percentage of participants who died from any cause during the treatment phase is presented. All deaths were adjudicated by an expert committee independent of the Sponsor.

Time frame: Up to 52 weeks

Population: The APaT population consisted of all randomized participants who received at least one dose of study treatment.

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.

Time frame: Up to 52 weeks

Population: The all participants as treated (APaT) population consisted of all randomized participants who received at least one dose of study treatment.

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.

Time frame: Up to 52 weeks

Population: The APaT population consisted of all randomized participants who received at least one dose of study treatment.

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.

Time frame: Up to 52 weeks

Population: The APaT population consisted of all randomized participants who received at least one dose of study treatment.

Participants had bicarbonate levels assessed throughout the 52-week treatment period. The percentage of participants who had any bicarbonate level that was \> the ULN of 33 mEq/L during the treatment phase is presented.

Time frame: Up to 52 weeks

Population: 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.

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.

Time frame: Up to 52 weeks

Population: 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.

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.

Time frame: Up to 52 weeks

Population: 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.

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.

Time frame: Up to 52 weeks

Population: 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.

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.

Time frame: Up to 52 weeks

Population: 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.

Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was \>=10 x ULN and had associated muscle spasms during the treatment phase is presented.

Time frame: Up to 52 weeks

Population: 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.

Participants had AST and ALT levels assessed throughout the 52-week treatment period. The percentage of participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater during the treatment phase is presented.

Time frame: Up to 52 weeks

Population: 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.

Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was \>=10 x ULN during the treatment phase is presented.

Time frame: Up to 52 weeks

Population: 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.

Participants had potassium levels assessed throughout the 52-week treatment period. The percentage of participants who had any potassium level that was \< the LLN of 3.5 mEq/L during the treatment phase is presented.

Time frame: Up to 52 weeks

Population: 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.

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.

Time frame: Up to 52 weeks

Population: 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.

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 \[Week 52\]).

Time frame: Baseline and Week 52

Population: 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.

The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of Apo A-1 for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Time frame: Baseline and Week 52

Population: The FAS population consisted of all randomized participants who received at least one dose of study treatment and 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.

The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of apolipoprotein (Apo) B for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Time frame: Baseline and Week 52

Population: The FAS population consisted of all randomized participants who received at least one dose of study treatment and 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.

The efficacy of adding anacetrapib 100 mg relative to placebo on plasma concentrations of high-density lipoprotein cholesterol (HDL-C) was evaluated at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Time frame: Baseline and Week 52

Population: The FAS population consisted of all randomized participants who received at least one dose of study treatment and 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.

The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of lipoprotein(a) (Lp\[a\]) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Time frame: Baseline and Week 52

Population: The FAS population consisted of all randomized participants who received at least one dose of study treatment and 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.

The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of non-high-density lipoprotein cholesterol (HDL-C) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

Time frame: Baseline and Week 52

Population: The FAS population consisted of all randomized participants who received at least one dose of study treatment and 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.