A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome

NCT ID: NCT02968160

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-02-28

Brief Summary

This is a Randomized, open-label, 2 groups, parallel design.

Detailed Description

This study objective is to compare the safety and efficacy between fixed dose combination (Duowell® tab) and free pill combination therapy of Telmisartan and Rosuvastatin in hypertensive and hypercholesterolemic patients with metabolic syndrome.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telmisartan+Rosuvastatin

Duowell ® tablet (Telmisartan 40mg + Rosuvastatin 20mg) 1 tablet, once daily, Oral administration/ 8 weeks

• But, the increased Duowell ® tablet (Telmisartan 80mg + Rosuvastatin 20mg) will get administrated orally one tablet once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.

Group Type: EXPERIMENTAL

Telmisartan 40mg + Rosuvastatin 20mg

Intervention Type: DRUG

Telmisartan 80mg + Rosuvastatin 20mg

Intervention Type: DRUG

Telmisartan/Rosuvastatin

Telmisartan 40mg + Rosuvastatin 20mg 2 tablets, once daily, Oral administration/ 8 weeks

• But, the increased Telmisartan 80mg + Rosuvastatin 20mg will get administrated orally 2 tablets once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.

Group Type: ACTIVE_COMPARATOR

Telmisartan 40mg, 80 mg

Intervention Type: DRUG

Rosuvastatin 20mg

Intervention Type: DRUG

Interventions

Telmisartan 40mg + Rosuvastatin 20mg

Intervention Type: DRUG

Telmisartan 80mg + Rosuvastatin 20mg

Intervention Type: DRUG

Telmisartan 40mg, 80 mg

Intervention Type: DRUG

Rosuvastatin 20mg

Intervention Type: DRUG

Other Intervention Names

Duowell ® tablet; Duowell ® tablet; Micardis tablet; Monorova tablet

Eligibility Criteria

Inclusion Criteria

• Aged between 19 and 79 years old at screening visit
• Subjects who have being used anti-hypertension drugs and Lipid lowering agents over 4weeks before randomization.
• Subjects who have been diagnosed with metabolic syndrome according to following criteria Definition of patients with metabolic syndrome: Patients satisfy two of the following criteria at least

• Abdominal obesity: Waist measurement > 90 cm(male), > 80 cm(female)
• Triglyceride(TG) ≥ 150 mg/dL(
• High-Density Lipoprotein Cholesterol(HDL-C) < 40 mg/dL(male), < 50 mg/dL (female)
• Fasting Plasma Glucose(FPG) ≥ 100 mg/dL or Subject who has being used oral hypoglycemic agents
• Childbearing potential women have certainly negative of the pregnancy test at screening visit (visit 1), and agree to implement the effective contraception during the study period(including the medically non-pregnant state)
• Subjects who have signed after fully understanding the purpose, content, characteristics and risk of the investigational product and get explained enough.

Exclusion Criteria

• Subjects who taking anti-hypertension drugs more than three agent
• Subjects who have mean Sitting Systolic Blood Pressure(siSBP) > 160 mmHg (excluded if appliable, one of the arms)
• Subjects who have blood pressure ≥ 140/90 mmHg with taking 2 or more anti-hypertension drugs (except if any of the arms)
• Subjects that Low Density Lipoprotein-Cholesterol(LDL-C) isn't properly controlled according to National Cholesterol Education Program Adults Treatment Panel (NCEP ATP) III criteria
• Subjects who have triglyceride (TG) ≥ 400mg/dL
• Subjects who have a difference more than 20mmHg at the mean Sitting Diastolic Blood Pressure(siSBP) measured three times in both arms.
• Other exclusions applied

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linical Korea

INDUSTRY

Sponsor Role: collaborator

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dongguk University Medical Center

Ilsan, , South Korea

Countries

South Korea

Other Identifiers

YMC017

Identifier Type: -

Identifier Source: org_study_id