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

NCT ID: NCT03474562

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2019-06-07

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.

Conditions

ASCVD; Impaired Fasting Glucose; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duowell Tab

Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks

Group Type: EXPERIMENTAL

Duowell®

Intervention Type: DRUG

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

Monorova Tab + Amlopin Tab

Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks

Group Type: ACTIVE_COMPARATOR

Monorova® + Amlopin®

Intervention Type: DRUG

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

Interventions

Duowell®

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

Intervention Type: DRUG

Monorova® + Amlopin®

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Dankook University Hospital

Cheonan, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YMC032

Identifier Type: -

Identifier Source: org_study_id