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| ID | Type | Description | Link |
|---|---|---|---|
| 163314 | Registry Identifier | JAPIC-CTI | |
| MK-0653H-833 | Other Identifier | Merck Study Number |
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The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe 10 mg + Rosuvastatin 2.5 mg | Experimental | 1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein- cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may be increased to 5.0 mg |
|
| Ezetimibe 10 mg + Rosuvastatin 5.0 mg | Experimental | 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe | Drug |
| ||
| Rosuvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least 1 Adverse Event (AE) | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who reported at least 1 AE was summarized. | Up to 2 weeks post last dose of study drug (up to 54 weeks) |
| Percentage of Participants Who Had Study Drug Discontinued Due to an AE | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized. | up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Blood was collected at baseline (predose) and after 52 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by beta quantification ultracentrifugation. The percentage change from baseline at Week 52 was summarized. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Teramoto T, Yokote K, Nishida C, Oshima N, Takase T. A Phase III Open-label clinical trial to assess the long-term safety of ezetimibe and rosuvastatin combination therapy in Japanese patients with hypercholesterolemia. J Clin Therapeut Med. 2018;34(11):765-82. (in Japanese) https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2018&vo=34&issue=11 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe 10 mg + Rosuvastatin 2.5 mg | 1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2017 |
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| Drug |
|
| Baseline (predose) and Week 52 |
| Ezetimibe 10 mg + Rosuvastatin 5.0 mg |
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe 10 mg + Rosuvastatin 2.5 mg | 1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg |
| BG001 | Ezetimibe 10 mg + Rosuvastatin 5.0 mg | 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | Percentage of Participants Who Experience at Least 1 Adverse Event (AE) | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who reported at least 1 AE was summarized. | All participants who received at least 1 dose of study drug during treatment period. | Posted | Number | Percentage of Participants | Up to 2 weeks post last dose of study drug (up to 54 weeks) |
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| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Had Study Drug Discontinued Due to an AE | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized. | All participants who received at least 1 dose of study drug during treatment period. | Posted | Number | Percentage of Participants | up to 52 weeks |
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| ||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Blood was collected at baseline (predose) and after 52 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by beta quantification ultracentrifugation. The percentage change from baseline at Week 52 was summarized. | All participants that received at least 1 dose of study drug, had baseline data for those analyses that required baseline data and had post-baseline data for endpoint. | Posted | Mean | 95% Confidence Interval | Percentage change | Baseline (predose) and Week 52 |
|
|
Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
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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 | Ezetimibe 10 mg + Rosuvastatin 2.5 mg | 1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg | 0 | 114 | 2 | 114 | 53 | 114 |
| EG001 | Ezetimibe 10 mg + Rosuvastatin 5.0 mg | 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks. | 0 | 21 | 1 | 21 | 13 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Nov 5, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Participants |
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