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

NCT ID: NCT05643508

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2024-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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(D) DWC202206 + DWC202207

Group Type EXPERIMENTAL

(D) DWC202206

Intervention Type DRUG

Drug of DWC202206 A mg

(D) DWC202207

Intervention Type DRUG

Drug of DWC202207 B/C mg

(P+D) DWC202206 + DWC202207

Group Type ACTIVE_COMPARATOR

(P) DWC202206

Intervention Type DRUG

Placebo of DWC202206 A mg

(D) DWC202207

Intervention Type DRUG

Drug of DWC202207 B/C mg

(D+P) DWC202206 + DWC202207

Group Type ACTIVE_COMPARATOR

(P) DWC202207

Intervention Type DRUG

Placebo of DWC202207 B/C mg

(D) DWC202206

Intervention Type DRUG

Drug of DWC202206 A mg

Interventions

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(P) DWC202206

Placebo of DWC202206 A mg

Intervention Type DRUG

(P) DWC202207

Placebo of DWC202207 B/C mg

Intervention Type DRUG

(D) DWC202206

Drug of DWC202206 A mg

Intervention Type DRUG

(D) DWC202207

Drug of DWC202207 B/C mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW_DWJ1575301

Identifier Type: -

Identifier Source: org_study_id