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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duowell Tab | Experimental | Telmisartan 40mg/Rosuvastatin 20mg qd for 24 weeks |
|
| Monorova Tab + Amlopin Tab | Active Comparator | Rosuvastatin 20mg + Amlodipine 5mg qd for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duowell® | Drug | Telmisartan/Rosuvastatin 40/20mg (increased to Telmisartan 80mg if SBP > 140mmHg or DBP > 90mmHg at week 12) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 24 in homeostasis model assessment for insulin resistance (HOMA-IR) | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
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
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:
Exclusion Criteria:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | South Korea | |||
| Dankook University Hospital |
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| Monorova® + Amlopin® | Drug | Rosuvastatin 20mg + Amlodipine 5mg (increased to Amlodipine 10mg if SBP > 140mmHg or DBP > 90mmHg at week 12) |
|
| 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 |
| 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 C-reactive protein (CRP) | Baseline, Week 12, Week 24 |
| Cheonan |
| South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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