NCT02842359.
Methods | Randomised, open‐label, parallel‐assignment trial |
Participants | Aged ≥ 19 years to < 75 years No medication history of hyperlipidaemia and hypertension within 3 months following registration, among people with type 2 diabetes diagnosed with hyperlipidaemia and stage I hypertension (systolic blood pressure: ≥ 140 mmHg, ≤ 159 mmHg or diastolic blood pressure: ≥ 90 mmHg, ≤ 99 mmHg), with adequately controlled haemoglobin levels Diagnosis of diabetes: haemoglobin A1c ≥ 6.5% or; fasting plasma glucose level above 8 hour ≥ 126 mg/dL or plasma glucose ≥ 200 mg/dL ( 11.1 mmol/l) 2 h after a 75 g glucose load or symptoms (such as polyuria, polydipsia, unexplained weight loss) and a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) |
Interventions | Irbesartan/atorvastatin fixed‐dose combination: pharmaceutical form: tablet; route of administration: oral; other name: Rovelito Comparators Irbesartan SR47436: pharmaceutical form: tablet; route of administration: oral; other name: Aprovel Atorvastatin: pharmaceutical form: tablet; route of administration: oral; other name: Newvast |
Outcomes |
Primary outcomes: (time frame: 4 weeks‐maximum 5 weeks)
Secondary outcomes: (Time frame: 4 weeks up to maximum 5 weeks)
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Notes |