Clinical trial

A Randomized, Double-blind, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Hypertension and Dyslipidemia

Name

DW_DWJ1575301

Description

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

Trial arms

Trial start

2022-12-01

Estimated PCD

2024-03-01

Trial end

2024-03-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

(D) DWC202206

Drug of DWC202206 A mg

Arms:

(D) DWC202206 + DWC202207, (D+P) DWC202206 + DWC202207

(D) DWC202207

Drug of DWC202207 B/C mg

Arms:

(D) DWC202206 + DWC202207, (P+D) DWC202206 + DWC202207

(P) DWC202206

Placebo of DWC202206 A mg

Arms:

(P+D) DWC202206 + DWC202207

(P) DWC202207

Placebo of DWC202207 B/C mg

Arms:

(D+P) DWC202206 + DWC202207

Size

192

Primary endpoint

The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm

8 weeks

The change of LDL-C based on baseline between treatment arm and control 2 arm

8 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 192, 'type': 'ESTIMATED'}}

Updated at

2022-12-12

1 organization

2 products

2 indications

Product

Indication

Indication

Product

Organization

Daewoong Pharmaceutical Co. LTD.