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

Yuhan

Status and phase: Completed; Phase 4

Conditions: Hypertension; Impaired Fasting Glucose; ASCVD

Treatments: Drug: Duowell®; Drug: Monorova® + Amlopin®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03474562

YMC032

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent

2. Aged 19 to 75 years

3. 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

4. Those who are taking antihypertensive drugs, or SBP > 140mmHg or DBP > 90mmHg on the left side

5. 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

1. Those who are treated with secondary hypertension or malignant hypertension

2. Uncontrollable diabetes with HbA1c ≥ 10%

3. Total cholesterol ≥ 300mg/dL

4. Fasting LDL-C ≤ 70 mg/dL

5. Fasting triglyceride ≥ 500 mg/dL

6. History of muscular disease or rhabdomyolysis due to use of statin

7. Hypersensitive to statin or ARBs

8. 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

9. Those who are participating in clinical trials of other investigational products

10. 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

11. Other than the above who is deemed to be ineligible to participate in the trial by investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Duowell Tab

Experimental group

Description:

Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks

Treatment:

Drug: Duowell®

Monorova Tab + Amlopin Tab

Active Comparator group

Description:

Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks

Treatment:

Drug: Monorova® + Amlopin®