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A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02748057
Recruitment Status : Completed
First Posted : April 22, 2016
Results First Posted : December 4, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypercholesterolemia
Familial Hypercholesterolemia
Interventions Drug: Ezetimibe
Drug: Rosuvastatin
Enrollment 135
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ezetimibe 10 mg + Rosuvastatin 2.5 mg Ezetimibe 10 mg + Rosuvastatin 5.0 mg
Hide Arm/Group Description 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 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
Period Title: Overall Study
Started 114 21
Completed 109 19
Not Completed 5 2
Reason Not Completed
Adverse Event             1             0
Physician Decision             0             1
Protocol Violation             2             1
Participant Moved             1             0
Withdrawal by Subject             1             0
Arm/Group Title Ezetimibe 10 mg + Rosuvastatin 2.5 mg Ezetimibe 10 mg + Rosuvastatin 5.0 mg Total
Hide Arm/Group Description 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 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 114 21 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 21 participants 135 participants
58.2  (10.8) 52.4  (13.3) 57.3  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 21 participants 135 participants
Female
61
  53.5%
9
  42.9%
70
  51.9%
Male
53
  46.5%
12
  57.1%
65
  48.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 21 participants 135 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
114
 100.0%
21
 100.0%
135
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
Hide Description 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.
Time Frame Up to 2 weeks post last dose of study drug (up to 54 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug during treatment period.
Arm/Group Title Ezetimibe 10 mg + Rosuvastatin 2.5 mg Ezetimibe 10 mg + Rosuvastatin 5.0 mg
Hide Arm/Group Description:
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
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
Overall Number of Participants Analyzed 114 21
Measure Type: Number
Unit of Measure: Percentage of Participants
72.8 76.2
2.Primary Outcome
Title Percentage of Participants Who Had Study Drug Discontinued Due to an AE
Hide Description 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.
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug during treatment period.
Arm/Group Title Ezetimibe 10 mg + Rosuvastatin 2.5 mg Ezetimibe 10 mg + Rosuvastatin 5.0 mg
Hide Arm/Group Description:
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
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
Overall Number of Participants Analyzed 114 21
Measure Type: Number
Unit of Measure: Percentage of Participants
0.9 0.0
3.Secondary Outcome
Title Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Hide Description 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.
Time Frame Baseline (predose) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ezetimibe 10 mg + Rosuvastatin 2.5 mg Ezetimibe 10 mg + Rosuvastatin 5.0 mg
Hide Arm/Group Description:
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
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
Overall Number of Participants Analyzed 108 17
Mean (95% Confidence Interval)
Unit of Measure: Percentage change
-33.8
(-36.9 to -30.8)
-23.9
(-29.1 to -18.6)
Time Frame Up to 2 weeks post last dose of study drug (up to 54 weeks)
Adverse Event Reporting Description Population included all participants who received at least 1 dose of study drug during treatment period.
 
Arm/Group Title Ezetimibe 10 mg + Rosuvastatin 2.5 mg Ezetimibe 10 mg + Rosuvastatin 5.0 mg
Hide Arm/Group Description 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 1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
All-Cause Mortality
Ezetimibe 10 mg + Rosuvastatin 2.5 mg Ezetimibe 10 mg + Rosuvastatin 5.0 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)      0/21 (0.00%)    
Hide Serious Adverse Events
Ezetimibe 10 mg + Rosuvastatin 2.5 mg Ezetimibe 10 mg + Rosuvastatin 5.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/114 (1.75%)      1/21 (4.76%)    
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/114 (0.00%)  0 1/21 (4.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Intestinal adenocarcinoma  1  1/114 (0.88%)  1 0/21 (0.00%)  0
Psychiatric disorders     
Anxiety disorder  1  1/114 (0.88%)  1 0/21 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ezetimibe 10 mg + Rosuvastatin 2.5 mg Ezetimibe 10 mg + Rosuvastatin 5.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/114 (46.49%)      13/21 (61.90%)    
Infections and infestations     
Gastroenteritis  1  8/114 (7.02%)  8 1/21 (4.76%)  2
Nasopharyngitis  1  41/114 (35.96%)  69 8/21 (38.10%)  18
Rhinitis  1  1/114 (0.88%)  1 2/21 (9.52%)  2
Injury, poisoning and procedural complications     
Contusion  1  2/114 (1.75%)  2 2/21 (9.52%)  3
Investigations     
Liver function test abnormal  1  3/114 (2.63%)  3 2/21 (9.52%)  2
Metabolism and nutrition disorders     
Type 2 diabetes mellitus  1  3/114 (2.63%)  3 2/21 (9.52%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  9/114 (7.89%)  11 1/21 (4.76%)  1
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Publications of Results:
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
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02748057    
Other Study ID Numbers: 0653H-833
163314 ( Registry Identifier: JAPIC-CTI )
MK-0653H-833 ( Other Identifier: Merck Study Number )
First Submitted: April 20, 2016
First Posted: April 22, 2016
Results First Submitted: November 5, 2018
Results First Posted: December 4, 2018
Last Update Posted: April 2, 2019