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

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02968160
• Other study ID #: YMC017
• Status: Terminated
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: May 2017
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Drug:
• Telmisartan 40mg + Rosuvastatin 20mg

• Telmisartan 80mg + Rosuvastatin 20mg

• Telmisartan 40mg, 80 mg

• Rosuvastatin 20mg

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Medical Center	Ilsan

Sponsors (2)

Lead Sponsor	Collaborator
Yuhan Corporation	Linical Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration.		week 8
Secondary	Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks		From baseline to 4 and 8 weeks
Secondary	Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks		From baseline to 4 and 8 weeks
Secondary	The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks		4 and 8 weeks
Secondary	The proportion of subjects that the Low Density Lipoprotein-Cholesterol(LDL-C) level reaches treatment goals in accordance with guideline of National Cholesterol Education Program-Adult Treatment Panel(NCEP ATP) III to 4 and 8 weeks		4 and 8 weeks
Secondary	Change of below indicators from baseline to 4 and 8 weeks		baseline to 4 and 8 weeks