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Clinical Trials/NCT03474562
NCT03474562CompletedPhase 4

Effect of High-Dose Rosuvastatin Combined With Telmisartan or Amlodipine on Glucose Metabolism in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Impaired Fasting Glucose (IFG) and Hypertension: A Randomized, Open-Label, Parallel, Prospective Study

Yuhan Corporation4 sites in 1 country100 target enrollmentStarted: April 3, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
100
Locations
4
Primary Endpoint
Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and hypertension.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Written informed consent
  • •Aged 19 to 75 years
  • •Patients with ASCVD requiring high-intensity statin therapy (in accordance with the clinical ASCVD diagnostic criteria in the 2013 ACC/AHA Guideline)
  • •Coronary artery disease
  • •acute coronary syndrome
  • •history of myocardial infarction (MI)
  • •stable or unstable angina
  • •history of coronary revascularization
  • •stroke or transient ischemic attack (TIA)
  • •peripheral arterial disease, history of peripheral arterial revascularization
  • •Those who are taking antihypertensive drugs, or SBP > 140mmHg or DBP > 90mmHg on the left side
  • •High-risk group (except for gestational diabetes) who has not been diagnosed with diabetes before, and who falls under one of the following criteria:
  • •impaired fasting glucose (IFG): 100-125 mg/dL (5.6-6.9 mmol/L)
  • •impaired glucose tolerance (IGT): plasma blood glucose 140-199mg/dL (7.8 to 11.0 mmol/L) 2 hours after oral administration of glucose 75g
  • •HbA1c: 5.7-6.4%

Exclusion Criteria

  • •Those who are treated with secondary hypertension or malignant hypertension
  • •Uncontrollable diabetes with HbA1c ≥ 10%
  • •Total cholesterol ≥ 300mg/dL
  • •Fasting LDL-C ≤ 70 mg/dL
  • •Fasting triglyceride ≥ 500 mg/dL
  • •History of muscular disease or rhabdomyolysis due to use of statin
  • •Hypersensitive to statin or ARBs
  • •Contraindications stated in the SPC of telmisartan or rosuvastatin including the following:
  • •severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
  • •ALT, AST > 3x ULN or history of active liver disease
  • •CPK > 3x ULN
  • •hyperkalemia with serum K > 5.5 mEq/l
  • •Those who are participating in clinical trials of other investigational products
  • •Those who cannot discontinue all other treatment for hypertension or hyperlipidemia than the investigational products, and concomitant medications and supplements that can affect the therapeutic effect of hypertension and hyperlipidemia during the trial period
  • •Other than the above who is deemed to be ineligible to participate in the trial by investigator

Arms & Interventions

Duowell Tab

Experimental

Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks

Intervention: Duowell® (Drug)

Monorova Tab + Amlopin Tab

Active Comparator

Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks

Intervention: Monorova® + Amlopin® (Drug)

Outcomes

Primary Outcomes

Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)

Time Frame: Baseline, Week 24

Secondary Outcomes

  • Change from baseline to week 12 and week 24 in insulin level(Baseline, Week 12, Week 24)
  • Change from baseline to week 12 and week 24 in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)(Baseline, Week 12, Week 24)
  • Change from baseline to week 12 and week 24 in HOMA-IR(Baseline, Week 12, Week 24)
  • Change from baseline to week 12 and week 24 in hemoglobin A1c (HbA1c)(Baseline, Week 12, Week 24)
  • Change from baseline to week 12 and week 24 in C-reactive protein (CRP)(Baseline, Week 12, Week 24)
  • Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)(Baseline, Week 12, Week 24)
  • Change from baseline to week 12 and week 24 in homeostatic model assessment for β-cell function (HOMA-B)(Baseline, Week 12, Week 24)

Investigators

Sponsor
Yuhan Corporation
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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