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NCT05643508 Clinical Trial

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

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05643508
Other study ID # DW_DWJ1575301
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date December 2022
Est. completion date March 2024

Study information
Verified date December 2022
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 192
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• (D) DWC202206
Drug of DWC202206 A mg
• (D) DWC202207
Drug of DWC202207 B/C mg
• (P) DWC202206
Placebo of DWC202206 A mg
• (P) DWC202207
Placebo of DWC202207 B/C mg

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome
Type Measure Description Time frame Safety issue
Primary The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm 8 weeks
Primary The change of LDL-C based on baseline between treatment arm and control 2 arm 8 weeks
Secondary The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm 4 weeks
Secondary The change of LDL-C based on baseline between treatment arm and control 2 arm 4 weeks
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