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NCT Number: NCT05643508

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kangbuk Samsung Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(D) DWC202206

Drug

Drug of DWC202206 A mg

(D) DWC202207

Drug

Drug of DWC202207 B/C mg

(P) DWC202206

Drug

Placebo of DWC202206 A mg

(P) DWC202207

Drug

Placebo of DWC202207 B/C mg

Primary outcomes

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2022
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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