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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_506 |
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This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima media thickening using ultrasound compared to patients taking placebo. There will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK0524A |
|
| 2 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: niacin (+) laropiprant (MK0524A) | Drug | niacin (+) laropiprant (2 g) po qd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Carotid Intima Media Thickness | change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery. | after 96 weeks of postrandomization treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lipid Profile | after 96 weeks of postrandomization treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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There was an MK0524A active run-in period prior to randomization. Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, for an additional 4 weeks prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK0524A Active Run-In Period | Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization. |
| FG001 | MK0524A, 2 g (Postrandomization Period) | Patients who were randomized to MK0524A, 2 g (oral administration) once daily. |
| FG002 | Placebo (Postrandomization Period) | Patients who were randomized to placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MK0524A Active Run-In, Pre-randomization |
|
| |||||||||||||||||||||||||||
| Post-randomization Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK0524A, 2 g (Postrandomization Period) | Patients who were randomized to MK0524A, 2 g (oral administration) once daily. |
| BG001 | Placebo (Postrandomization Period) | Patients who were randomized to placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Carotid Intima Media Thickness | change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery. | study prematurely terminated, no efficacy analyses were performed | Posted | after 96 weeks of postrandomization treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK0524A Active Run-In Period | Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
After a detailed review of pooled carotid IMT data from contemporary studies, the Steering Committee recommended that Merck prematurely stop the study; as designed, the study was significantly underpowered. Efficacy analyses were not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C518174 | MK-0524 |
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| Comparator: placebo | Drug | niacin (+) laropiprant (2 g) placebo po qd. |
|
| Withdrawal by Subject |
|
| Not cIMT eligible at Visit 3 |
|
| Trial Termination |
|
| Certified Sonographer Not Available |
|
| Patient Unable to Complete cIMT Scan |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
| OG002 | Placebo (Postrandomization Period) | Patients who were randomized to placebo |
|
| Secondary | Change in Lipid Profile | study prematurely terminated, no efficacy analyses were performed | Posted | after 96 weeks of postrandomization treatment |
|
|
| 10 |
| 395 |
| EG001 | MK0524A, 2 g (Postrandomization Period) | Patients who were randomized to MK0524A, 2 g (oral administration) once daily. | 5 | 74 |
| EG002 | Placebo (Postrandomization Period) | Patients who were randomized to placebo | 8 | 54 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Acute pectoris | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Toe deformity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Burning Sensation | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |