A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia

Hanlim Pharm. Co., Ltd.1 site in 1 country156 target enrollmentJuly 15, 2020

ConditionsPrimary Hypercholesterolemia Hypertension

DrugsExperimental : Ezetimibe / Rosuvastatin + Telmisartan Active comparator1 : Ezetimibe / Rosuvastatin Active comparator2 : Telmisartan

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Primary Hypercholesterolemia
Sponsor: Hanlim Pharm. Co., Ltd.
Enrollment: 156
Locations: 1
Primary Endpoint: Mean sitting systolic blood pressure (MSSBP)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multicenter, Randomized, double-blind, acitve-controlled, Phase 3 Clinical Trial in 8 weeks for screening, twice Investigational product administer, Follow up visit.

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in patients with essential hypertension and primary hypercholesterolemia.

Registry

clinicaltrials.gov

Start Date

July 15, 2020

End Date

May 19, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hanlim Pharm. Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult male and female aged 19 to 79 years of age
•a patient with congenital hypertension and hypercholesterolemia capable of administering medicines for Clinical trials planned for this clinical trial, with the discontinuation of existing therapeutic drugs according to the section.
•A person who meets the following criteria at the time of screening (visit 1)
•MSSBP \< 180mmHg and MSDBP \< 110mmHg
•LDL-C ≤ 250 mg/dL and TG \< 400 mg/dL (based on organ clinical laboratory testing)
•A person who agrees to contraception through a medically permitted contraception method during a clinical trial period.
•Possible pregnant female test subjects: intrauterine device (IUD) or IUS (Intrauterine system), intractorine defections, double-blocking method (complex use of blocking methods such as male condoms, female condoms, uterine cervical caps, contraceptive diaphragm, contraceptive sponges)
•Male test subjects with potential pregnant spouses (including partners): hormonal contraception, intrauterine device (IUD) or IUS (Intrauterine system), intraperitoneal failure, double-blocking (male condom, female condom, uterine cervical cap, contraceptive diaphragm, and contraceptive blocking)
•Patients who have agreed in writing to voluntarily participate in this clinical trial
•Randomized(Visit 2) criteria

Exclusion Criteria

•A person suspected of secondary hypertension or secondary hypertension (aortic stenosis, hyperaldosterone haemorrhage, renal vein stenosis, sacrosanctal hypertension, chrome-friendly cell species, Cushing syndrome, polycystic neuropathy, etc.)
•Secondary dyslipidemia patients (neurological syndrome, dysplasia, closed liver disease, Cushing syndrome, etc.)
•Standing low blood pressure patient with symptoms
•Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial fibrillation, or other arrhythmia patients that the tester has determined to be clinically meaningful.
•Persons with non-post-closing myocardial disease, severe closed coronary artery disease, aortic stenosis, hemodynamically meaningful aortic valve or mitral valve stenosis.
•Patients with severe heart failure (NYHA class III: Symptoms due to mild exercise/classIV: Symptoms even when stabilized)
•A person who has one or more of the following forces within the last six months based on a screening visit (visit 1):
•Those who have received ischemic heart disease (unstable angina, myocardial infarction), peripheral vascular disease, percutaneous coronary artery extension or coronary artery bypass treatment, etc.
•Patients with severe cerebrovascular disorders (brain stroke, cerebral infarction, cerebral hemorrhage, routine ischemia, etc.)
•A person with a history of gastrointestinal diseases (such as Crohn's disease, ulcers, etc.) and surgery (except simple appendectomy or hernia surgery) that can affect the absorption, distribution, metabolism, and excretion of drugs.