Clinical trial NCT02968160: A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Metabolic Syndrome
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
Collaborators: name: Linical Korea
First posted: 2016-11-18
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: week 8
Secondary outcomes:
measure: Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks
timeFrame: From baseline to 4 and 8 weeks
measure: Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks
timeFrame: From baseline to 4 and 8 weeks
measure: The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks
timeFrame: 4 and 8 weeks
measure: 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
timeFrame: 4 and 8 weeks
measure: Change of below indicators from baseline to 4 and 8 weeks
timeFrame: baseline to 4 and 8 weeks
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Medical Center
Study officials:
References: