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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288038
• Other study ID #: SP-RE-003
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2017
• Last updated: September 15, 2017
• Start date: October 13, 2014
• Est. completion date: November 19, 2015

Study information

• Verified date: August 2017
• Source: Shin Poong Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: November 19, 2015
• Est. primary completion date: November 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

• Ezetimibe

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang-si
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Boramae Hospital	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Seoul
Korea, Republic of	Ajou University Hospital	Suwon-si
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Shin Poong Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline to 8 week in LDL-Cholesterol		baseline and 8 week
Secondary	Percent change from baseline to 4 week in LDL-Cholesterol		baseline and 4 week
Secondary	The change in the LDL-C level from the baseline to Week 4 and Week 8		baseline to 4 and 8 week
Secondary	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		baseline to 4 and 8 week
Secondary	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		baseline to 4 and 8 week
Secondary	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		baseline to 4 and 8 week