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

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474562
• Other study ID #: YMC032
• Status: Completed
• Phase: Phase 4
• Start date: April 3, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: May 2021
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• ASCVD
• Hypertension
• Impaired Fasting Glucose

Intervention

Drug:
• Duowell®
Telmisartan/Rosuvastatin 40/20mg (increased to Telmisartan 80mg if SBP > 140mmHg or DBP > 90mmHg at week 12)
• Monorova® + Amlopin®
Rosuvastatin 20mg + Amlodipine 5mg (increased to Amlodipine 10mg if SBP > 140mmHg or DBP > 90mmHg at week 12)

Locations

Country	Name	City	State
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	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)		Baseline, Week 24
Secondary	Change from baseline to week 12 and week 24 in HOMA-IR		Baseline, Week 12, Week 24
Secondary	Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)		Baseline, Week 12, Week 24
Secondary	Change from baseline to week 12 and week 24 in insulin level		Baseline, Week 12, Week 24
Secondary	Change from baseline to week 12 and week 24 in homeostatic model assessment for ß-cell function (HOMA-B)		Baseline, Week 12, Week 24
Secondary	Change from baseline to week 12 and week 24 in hemoglobin A1c (HbA1c)		Baseline, Week 12, Week 24
Secondary	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
Secondary	Change from baseline to week 12 and week 24 in C-reactive protein (CRP)		Baseline, Week 12, Week 24