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

Primary Purpose

Metabolic Syndrome

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Telmisartan 40mg + Rosuvastatin 20mg
Telmisartan 80mg + Rosuvastatin 20mg
Telmisartan 40mg, 80 mg
Rosuvastatin 20mg
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dongguk University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telmisartan+Rosuvastatin

Telmisartan/Rosuvastatin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks
Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks
The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks
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
Change of below indicators from baseline to 4 and 8 weeks

Full Information

First Posted
November 10, 2016
Last Updated
April 10, 2019
Sponsor
Yuhan Corporation
Collaborators
Linical Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02968160
Brief Title
A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to poor enrollment rate
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
Collaborators
Linical Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telmisartan+Rosuvastatin
Arm Type
Experimental
Arm Description
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.
Arm Title
Telmisartan/Rosuvastatin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Telmisartan 40mg + Rosuvastatin 20mg
Other Intervention Name(s)
Duowell ® tablet
Intervention Type
Drug
Intervention Name(s)
Telmisartan 80mg + Rosuvastatin 20mg
Other Intervention Name(s)
Duowell ® tablet
Intervention Type
Drug
Intervention Name(s)
Telmisartan 40mg, 80 mg
Other Intervention Name(s)
Micardis tablet
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20mg
Other Intervention Name(s)
Monorova tablet
Primary Outcome Measure Information:
Title
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.
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks
Time Frame
From baseline to 4 and 8 weeks
Title
Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks
Time Frame
From baseline to 4 and 8 weeks
Title
The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks
Time Frame
4 and 8 weeks
Title
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
Time Frame
4 and 8 weeks
Title
Change of below indicators from baseline to 4 and 8 weeks
Time Frame
baseline to 4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dongguk University Medical Center
City
Ilsan
ZIP/Postal Code
10326
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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