Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as anacetrapib
MK0859 · 12 trials · 9 indications
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 \[Week 52\]).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Anacetrapib | EXPERIMENTAL | 100 mg tablet, oral, once daily for 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Matching tablet to Anacetrapib 100 mg, oral, once daily for 24 weeks |
| Anacetrapib 100 mg | EXPERIMENTAL | - |
| Anacetrapib 25 mg | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | MK0859 10 mg + placebo |
| 2 | EXPERIMENTAL | MK0859 40 mg + placebo |
| 3 | EXPERIMENTAL | MK0859 100 mg + placebo |
| 4 | EXPERIMENTAL | MK0859 300 mg + placebo |
| 5 | EXPERIMENTAL | MK0859 10 mg + atorvastatin 10mg |
| 6 | EXPERIMENTAL | MK0859 40 mg + atorvastatin 10mg |
| 7 | EXPERIMENTAL | MK0859 100 mg + atorvastatin 10mg |
| 8 | EXPERIMENTAL | MK0859 300 mg + atorvastatin 10mg |
| 9 | PLACEBO_COMPARATOR | Placebo + atorvastatin 10mg |
| 10 | PLACEBO_COMPARATOR | Placebo |
| Part 1 - Panel A | EXPERIMENTAL | Subjects with severe renal impairment |
| Part 1 - Panel B | EXPERIMENTAL | Healthy matched control subjects |
| Part 2 - Panel C | EXPERIMENTAL | Subjects with moderate renal impairment |
| Part 2 - Panel D | EXPERIMENTAL | Healthy matched control subjects |
| Part 2 - Panel E | EXPERIMENTAL | Subjects with mild renal impairment |
| Part 2 - Panel F | EXPERIMENTAL | Healthy matched control subjects |
| Part 1 - Group 1 | EXPERIMENTAL | Moderate Hepatic Patients |
| Part 1 - Group 2 | EXPERIMENTAL | Healthy Subjects |
| Part 2 - Group 1 | EXPERIMENTAL | Mild Hepatic Patients |
| Part 2 - Group 2 | EXPERIMENTAL | Healthy Subjects |
| Panel A | EXPERIMENTAL | Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859 |
| Panel B | EXPERIMENTAL | Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin |
| Name | Type | Description |
|---|---|---|
| Anacetrapib | DRUG | - |
| Placebo | DRUG | - |
| Placebo for anacetrapib | DRUG | - |
| Anacetrapib 100 mg | DRUG | 100 mg tablet, oral, once daily for 24 weeks |
| Placebo for anacetrapib 100 mg | DRUG | Placebo tablet, orally, once daily for 24 weeks |
| Anacetrapib 25 mg | DRUG | 25 mg tablet, oral, once daily for 24 weeks |
| Placebo for anacetrapib 25 mg | DRUG | Placebo tablet, orally, once daily for 24 weeks |
| Comparator: placebo | DRUG | Participants will receive one placebo tablet once daily for 76 weeks. |
| Comparator: atorvastatin | DRUG | atorvastatin tablet, 10mg, once daily for 8 weeks |
| Comparator: placebo to MK0859 | DRUG | Placebo to MK0859 once daily for 4 weeks. |
| Comparator: placebo to atorvastatin | DRUG | Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2. |
| MK0859 | DRUG | - |
Inclusion Criteria: * If female, cannot be of reproductive potential * Has been treated with an appropriate dose of statin for at least 6 weeks * Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LD...
MK0859 is an investigational small molecule being studied for hypercholesterolemia and ambulatory blood pressure. It was evaluated in Phase 1 clinical trials for these conditions, including primary hypercholesterolemia and mixed hyperlipidemia. The drug is not approved and remains in clinical development.
MK0859 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company sponsored Phase 1 clinical trials to investigate the drug's effects on blood pressure and cholesterol levels.
MK0859 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one studying its influence on ambulatory blood pressure and another in patients with primary hypercholesterolemia or mixed hyperlipidemia. The drug is investigational and not FDA approved.
MK0859 has been studied in two completed Phase 1 trials. NCT00565006 investigated its influence on ambulatory blood pressure in healthy volunteers aged 45 years and older. NCT00565292 studied the drug in patients with primary hypercholesterolemia or mixed hyperlipidemia aged 18 years and older.
MK0859 is an investigational small molecule distinct from approved cholesterol medications. It has been tested in Phase 1 trials for hypercholesterolemia and blood pressure, but it is not approved and its mechanism of action has not been disclosed in available information.