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

NCT03474562 | Completed Phase 4

• 1 other identifier: YMC032
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)

  Baseline, Week 24

Secondary Outcomes (7)

• 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 fasting plasma glucose (FPG)

  Baseline, Week 12, Week 24

• 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 homeostatic model assessment for β-cell function (HOMA-B)

  Baseline, Week 12, Week 24

• Change from baseline to week 12 and week 24 in hemoglobin A1c (HbA1c)

  Baseline, Week 12, Week 24

Study Arms (2)

Duowell Tab

EXPERIMENTAL

Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks

Drug: Duowell®

Monorova Tab + Amlopin Tab

ACTIVE COMPARATOR

Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks

Drug: Monorova® + Amlopin®

Interventions

Duowell® DRUG

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

Duowell Tab

Monorova® + Amlopin® DRUG

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

Monorova Tab + Amlopin Tab

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Aged 19 to 75 years
• 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
• Those who are taking antihypertensive drugs, or SBP \> 140mmHg or DBP \> 90mmHg on the left side
• 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%

You may not qualify if:

• Those who are treated with secondary hypertension or malignant hypertension
• Uncontrollable diabetes with HbA1c ≥ 10%
• Total cholesterol ≥ 300mg/dL
• Fasting LDL-C ≤ 70 mg/dL
• Fasting triglyceride ≥ 500 mg/dL
• History of muscular disease or rhabdomyolysis due to use of statin
• Hypersensitive to statin or ARBs
• 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
• Those who are participating in clinical trials of other investigational products
• 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
• Other than the above who is deemed to be ineligible to participate in the trial by investigator

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (4)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Location

Dankook University Hospital

Cheonan, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 22, 2018
• Study Start: April 3, 2018
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

KR (4)