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

Phase 4

Completed

• Conditions: Hypertension; ASCVD; Impaired Fasting Glucose
• Interventions: Drug: Monorova® + Amlopin®; Drug: Duowell®

• Registration Number: NCT03474562
• Lead Sponsor: Yuhan Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-22
• Study Start: 2018-04-03
• Primary Completion: 2019-06-07
• Study Completion: 2019-06-07
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monorova Tab + Amlopin Tab	Monorova® + Amlopin®	Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks
Duowell Tab	Duowell®	Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)	Baseline, Week 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Dankook University Hospital; 🇰🇷 Cheonan, Korea, Republic of

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of