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The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

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: NCT03288038
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Shin Poong Pharmaceutical Co. Ltd.

Brief Summary:
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients with Primary Hypercholesterolemia

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin Drug: Ezetimibe Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : November 19, 2015
Actual Study Completion Date : November 19, 2015


Arm Intervention/treatment
Experimental: RSV5mg + EZE 10mg
Rosuvastatin 5mg/Ezetimibe 10mg
Drug: Rosuvastatin
Drug: Ezetimibe
Active Comparator: RSV5mg
Rosuvastatin 5mg
Drug: Rosuvastatin
Experimental: RSV10mg + EZE10mg
Rosuvastatin 10mg/ Ezetimibe 10mg
Drug: Rosuvastatin
Drug: Ezetimibe
Active Comparator: RSV10mg
Rosuvastatin 10mg
Drug: Rosuvastatin
Experimental: RSV20mg + EZE10mg
Rosuvastatin 20mg/Ezetimibe 10mg
Drug: Rosuvastatin
Drug: Ezetimibe
Active Comparator: RSV20mg
Rosuvastatin 20mg
Drug: Rosuvastatin



Primary Outcome Measures :
  1. Percent change from baseline to 8 week in LDL-Cholesterol [ Time Frame: baseline and 8 week ]

Secondary Outcome Measures :
  1. Percent change from baseline to 4 week in LDL-Cholesterol [ Time Frame: baseline and 4 week ]
  2. The change in the LDL-C level from the baseline to Week 4 and Week 8 [ Time Frame: baseline to 4 and 8 week ]
  3. The change and percent change in the levels of TC, TG, HDL-C, non-HDL-C, apolipoprotein B, and hs-CRP from the baseline to Week 4 and Week 8 [ Time Frame: baseline to 4 and 8 week ]
  4. The change and percent change in the ratios of LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, and Apo B/Apo A-I from the baseline to Week 4 and Week 8 [ Time Frame: baseline to 4 and 8 week ]
  5. The ratio of the subjects who have reached the target LDL-C level according to the NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Week 4 and Week 8 [ Time Frame: baseline to 4 and 8 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults aged 19 years or older
  2. Patients with primary hypercholesterolemia
  3. Patients who were informed about the purpose, method, effects, risks of this clinical study and have provided a written consent form signed by him/herself or by a representative
  4. those who show an LDL-C level of 250 mg/dL or below and a TG level of less than 350 mg/dL at the run-in period (Week -1), and fall under the criterion of requiring the administration of antidyslipidemic drug of NCEP ATP III

Exclusion Criteria:

  1. Patients with hypersensitivity to the investigational product or its ingredients
  2. Those with an uncontrolled hypertension (SBP ≧ 180 mmHg or DBP ≧ 100 mmHg)
  3. Those with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebral vascular disease, coronary artery bypass or coronary intervention within 3 months of screening date
  4. Those with a history of malignant tumor within 5 years
  5. Those with a history of myopathy or rhabdomyolysis
  6. Those who show clinically significant confirmed laboratory test results (1) Patients showing AST or ALT level of greater than 2 times the institutional upper limit of normal or those with active liver disease or chronic hepatitis (2) A serum creatinine level greater than 2 times the institutional upper limit of normal (3) HbA1c > 9% (4) Those with TSH level of greater than 1.5 times the institutional upper limit of normal (5) Those with CK level greater than 2 times the institutional upper limit of normal (However, except for an increase caused by a recent trauma, intramuscular injection or strenuous exercise)
  7. Those who were given, within 4 weeks prior to the baseline (8 weeks in case of fibrate) or are expected to be given during the study period, a drug that can have an effect on the efficacy assessment of the clinical study (eg: antidyslipidemic drug (statins, ezetimibe, fibrates, BAS, nicotinic acid and derivative, etc.), systemic glucocorticosteroids, steatolytic enzyme inhibitor, cyclosporine, HIV proteinase inhibitor, macrolide class antibiotics, etc.)
  8. Patients who were given estrogen within 3 months from the screening or those who are expected to be given an administration during the study period. (However, a patient who is under a hormone replacement therapy (HRT) will be allowed if no dose change is expected in the course of the clinical study.)
  9. Those with a history of alcohol or drug abuse
  10. Patients with a hereditary disorder of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  11. Pregnant or breast-feeding women
  12. Women of childbearing potential or men who do not intend to use an adequate contraceptive measure during the study period and for 4 weeks after the end of the study(Adequate contraception: Administration and transplantation of a progestin-only contraceptive pill, intrauterine device, condom, spermicidal agent, etc.)
  13. Patients who participated in another clinical study within 3 months from the screening date or have not had a washout period of at least 5 times the half-life of the active ingredient of the previously administered investigational product, whichever is longer
  14. Those with drug malabsorption
  15. Patients who has been judged by the investigator to be ineligible to participate in the clinical study

Information from the National Library of Medicine

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): NCT03288038


Locations
Show Show 20 study locations
Sponsors and Collaborators
Shin Poong Pharmaceutical Co. Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shin Poong Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT03288038    
Other Study ID Numbers: SP-RE-003
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors