Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension; Dyslipidemia

Treatments: Drug: Telmisartan + Amlodipine + Rosuvastatin; Drug: Telmisartan + Amlodipine; Drug: Telmisartan + Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03210532

DW1501-301

Details and patient eligibility

About

A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia

Enrollment: 129 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults both male and female who are ≥19,<80 years old
• at screening, 140mmHg≤ SBP<180mmHg & 90mmHg≤ DBP<110mmHg & LDL-C≤250mg/dL & triglyceride<400mg/dL

Exclusion criteria

• at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
• secondary hypertension or secondary dyslipidemia
• patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
• women who are pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 3 patient groups

Test

Experimental group

Description:

qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)

Treatment:

Drug: Telmisartan + Amlodipine + Rosuvastatin

Reference 1

Active Comparator group

Description:

qd PO, Micardis(telmisartan) + Crestor(rosuvastatin)

Treatment:

Drug: Telmisartan + Rosuvastatin

Reference 2

Active Comparator group

Description:

qd PO,Twynsta(telmisartan/amlodipine)

Treatment:

Drug: Telmisartan + Amlodipine