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Completed

NCT Number: NCT03474562

High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension

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.

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Key information

Conditions

ASCVD Cardiovascular Diseases Hypertension Impaired Fasting Glucose Vascular Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duowell®

Drug

Telmisartan/Rosuvastatin 40/20mg (increased to Telmisartan 80mg if SBP > 140mmHg or DBP > 90mmHg at week 12)

Monorova® + Amlopin®

Drug

Rosuvastatin 20mg + Amlodipine 5mg (increased to Amlodipine 10mg if SBP > 140mmHg or DBP > 90mmHg at week 12)

Primary outcomes

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

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Change from baseline to week 12 and week 24 in HOMA-IR

    Time frame: Baseline, Week 12, Week 24

  2. Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)

    Time frame: Baseline, Week 12, Week 24

  3. Change from baseline to week 12 and week 24 in insulin level

    Time frame: Baseline, Week 12, Week 24

  4. Change from baseline to week 12 and week 24 in homeostatic model assessment for β-cell function (HOMA-B)

    Time frame: Baseline, Week 12, Week 24

  5. Change from baseline to week 12 and week 24 in hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 12, Week 24

  6. 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)

    Time frame: Baseline, Week 12, Week 24

  7. Change from baseline to week 12 and week 24 in C-reactive protein (CRP)

    Time frame: Baseline, Week 12, Week 24

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2018
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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