CompletedPhase 4

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

South Korea100 participantsStarted 2018-04-03

Plain-language 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.

Who can participate

Age range19 Years – 75 Years

SexALL

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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)
✓. 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:

What they're measuring

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

Timeframe: Baseline, Week 24

Trial details

NCT IDNCT03474562

SponsorYuhan Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-07

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