A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
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|ClinicalTrials.gov Identifier: NCT02748057|
Recruitment Status : Completed
First Posted : April 22, 2016
Results First Posted : December 4, 2018
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Familial Hypercholesterolemia||Drug: Ezetimibe Drug: Rosuvastatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Open-label, Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Patients With Hypercholesterolemia Who Have Inadequate LDL-C Control on Ezetimibe or Rosuvastatin Monotherapy|
|Actual Study Start Date :||May 18, 2016|
|Actual Primary Completion Date :||December 11, 2017|
|Actual Study Completion Date :||December 11, 2017|
Experimental: 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 be increased to 5.0 mg
Experimental: 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.
- Percentage of Participants Who Experience at Least 1 Adverse Event (AE) [ Time Frame: Up to 2 weeks post last dose of study drug (up to 54 weeks) ]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.
- Percentage of Participants Who Had Study Drug Discontinued Due to an AE [ Time Frame: up to 52 weeks ]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.
- Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline (predose) and Week 52 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748057
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|