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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05643508
• Collaborator: (none)
• Enrollment: 192
• Arms: 3
• Anticipated Duration (Months): 15

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Hyperlipidemias	Drug: (D) DWC202206; Drug: (D) DWC202207; Drug: (P) DWC202206; Drug: (P) DWC202207	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (D) DWC202206 + DWC202207	Drug: (D) DWC202206; Drug of DWC202206 A mg; Drug: (D) DWC202207; Drug of DWC202207 B/C mg
Active Comparator: (P+D) DWC202206 + DWC202207	Drug: (D) DWC202207; Drug of DWC202207 B/C mg; Drug: (P) DWC202206; Placebo of DWC202206 A mg
Active Comparator: (D+P) DWC202206 + DWC202207	Drug: (D) DWC202206; Drug of DWC202206 A mg; Drug: (P) DWC202207; Placebo of DWC202207 B/C mg

Outcome Measures

Primary Outcome Measures

1. The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm [8 weeks]

2. The change of LDL-C based on baseline between treatment arm and control 2 arm [8 weeks]

Secondary Outcome Measures

1. The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm [4 weeks]

2. The change of LDL-C based on baseline between treatment arm and control 2 arm [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT05643508
• Other Study ID Numbers: DW_DWJ1575301
• First Posted: Dec 8, 2022
• Last Update Posted: Dec 12, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Hyperlipidemias; Hyperlipoproteinemias

Study Results

No Results Posted as of Dec 12, 2022