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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03474562
• Collaborator: (none)
• Enrollment: 100
• Locations: 4
• Arms: 2
• Actual Duration (Months): 14.1
• Patients Per Site: 25
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ASCVD; Impaired Fasting Glucose; Hypertension	Drug: Duowell®; Drug: Monorova® + Amlopin®	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 3, 2018
• Actual Primary Completion Date: Jun 7, 2019
• Actual Study Completion Date: Jun 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Duowell Tab Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks	Drug: Duowell®; Telmisartan/Rosuvastatin 40/20mg (increased to Telmisartan 80mg if SBP > 140mmHg or DBP > 90mmHg at week 12)
Active Comparator: Monorova Tab + Amlopin Tab Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks	Drug: Monorova® + Amlopin®; Rosuvastatin 20mg + Amlodipine 5mg (increased to Amlodipine 10mg if SBP > 140mmHg or DBP > 90mmHg at week 12)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Change from baseline to week 12 and week 24 in HOMA-IR [Baseline, Week 12, Week 24]

2. Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG) [Baseline, Week 12, Week 24]

3. Change from baseline to week 12 and week 24 in insulin level [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) [Baseline, Week 12, Week 24]

5. Change from baseline to week 12 and week 24 in hemoglobin A1c (HbA1c) [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) [Baseline, Week 12, Week 24]

7. Change from baseline to week 12 and week 24 in C-reactive protein (CRP) [Baseline, Week 12, Week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

2. 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

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

2. 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHA Bundang Medical Center	Seongnam-si	Gyeonggi-do	Korea, Republic of
2	Dankook University Hospital	Cheonan		Korea, Republic of
3	Gangnam Severance Hospital	Seoul		Korea, Republic of
4	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yuhan Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT03474562
• Other Study ID Numbers: YMC032
• First Posted: Mar 22, 2018
• Last Update Posted: Jun 2, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jun 2, 2021