A Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Concomitant Hypertension and Hyperlipidemia

Daewoong Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Hypertension; Hyperlipidemias

Treatments: Drug: (D) DWC202207; Drug: (D) DWC202206; Drug: (P) DWC202207; Drug: (P) DWC202206

Study type: Interventional

Funder types: Industry

Identifiers

NCT05643508

DW_DWJ1575301

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of co-administration of DWC202206 and DWC202207 in patients with concomitant hypertension and hyperlipidemia.

Full description

The study design is a randomized, double-blind, multicenter clinical trial. The patients were randomly assigned to each group. Primary endpoint was the change of MSSBP based on baseline between Treatment arm and control 1 arm and the change of LDL-C based on baseline between arm and control 2 arm.

Enrollment: 192 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 19 to 80 years
• Patients with hypertension and hyperlipidemias

Exclusion criteria

• Orthostatic hypotension
• History of ventricular tachycardia, atrial fibrillation
• Uncontrolled diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 3 patient groups

(D) DWC202206 + DWC202207

Experimental group

Treatment:

Drug: (D) DWC202206

Drug: (D) DWC202207

(P+D) DWC202206 + DWC202207

Active Comparator group

Treatment:

Drug: (P) DWC202206

Drug: (D) DWC202207

(D+P) DWC202206 + DWC202207

Active Comparator group

Treatment:

Drug: (D) DWC202206

Drug: (P) DWC202207