Trial intelligence / Profile preview

Duowell vs Rosuvastatin+Amlodipine in ASCVD with IFG

NCT03474562Phase 4

Key facts

Status: Completed
Start: Apr 2018
Primary completion: Jun 2019
Countries: 1
Sponsor: Yuhan
Modality: Implantable Devices, Transdermal Patches, Inhalation Devices

Drugs: telmisartan + rosuvastatin
Conditions: hypertension (HTN)dyslipidemiaatherosclerotic cardiovascular disease (ASCVD)

Overview

Phase 4, randomised, open-label trial of telmisartan + rosuvastatin in hypertension (HTN), dyslipidemia and atherosclerotic cardiovascular disease (ASCVD) (2 arms), sponsored by Yuhan. Primary endpoint: Homeostasis Model Assessment for Insulin Resistance at 24 weeks. Started Apr 2018; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Duowell Tab
Telmisartan 40mg/Rosuvastatin 20mg qd
Monorova Tab + Amlopin Tab
Rosuvastatin 20mg + Amlodipine 5mg qd

Who it enrols

Patients aged 19-75 with ASCVD requiring high-intensity statin therapy, hypertension, and impaired fasting glucose (pre-diabetes) but not diagnosed diabetes. Excludes severe renal/liver disease and those with LDL <= 70 mg/dL.

Endpoints

Primary

Homeostasis Model Assessment for Insulin Resistance24 weeks

Secondary

Homeostasis Model Assessment for Insulin Resistance24 weeks
Fasting Plasma Glucose24 weeks
Insulin Level24 weeks
Homeostatic Model Assessment for Beta-cell Function24 weeks
Hemoglobin A1c24 weeks
Total Cholesterol, Triglycerides, HDL-C, LDL-C24 weeks
C-Reactive Protein24 weeks

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