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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

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ClinicalTrials.gov Identifier: NCT05643508
Recruitment Status : Not yet recruiting
First Posted : December 8, 2022
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT05643508    
Other Study ID Numbers: DW_DWJ1575301
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Vascular Diseases
 Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases