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

NCT02968160 | Terminated Phase 4

• 1 other identifier: YMC017
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks

  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

  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

  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

  4 and 8 weeks

• Change of below indicators from baseline to 4 and 8 weeks

  baseline to 4 and 8 weeks

Study Arms (2)

Telmisartan+Rosuvastatin

EXPERIMENTAL

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.

Drug: Telmisartan 40mg + Rosuvastatin 20mg; Drug: Telmisartan 80mg + Rosuvastatin 20mg

Telmisartan/Rosuvastatin

ACTIVE COMPARATOR

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.

Drug: Telmisartan 40mg, 80 mg; Drug: Rosuvastatin 20mg

Interventions

Telmisartan 40mg + Rosuvastatin 20mg DRUG

Also known as: Duowell ® tablet

Telmisartan+Rosuvastatin

Telmisartan 80mg + Rosuvastatin 20mg DRUG

Also known as: Duowell ® tablet

Telmisartan+Rosuvastatin

Telmisartan 40mg, 80 mg DRUG

Also known as: Micardis tablet

Telmisartan/Rosuvastatin

Rosuvastatin 20mg DRUG

Also known as: Monorova tablet

Telmisartan/Rosuvastatin

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuhan Corporation: lead
• Linical Korea: collaborator

Study Sites (1)

Dongguk University Medical Center

Ilsan, 10326, South Korea

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Telmisartan; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 18, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 12, 2019

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)