A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022 in Patients With Primary Hypercholesterolemia and Essential Hypertension
Overview
- Phase
- Phase 3
- Intervention
- AD-2022
- Conditions
- Hypertension, Essential
- Sponsor
- Addpharma Inc.
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Low density lipoprotein cholesterol (LDL-C)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022
Detailed Description
Condition or disease : Primary Hypercholesterolemia and Essential Hypertension Intervention/treatment Drug : AD-2021 Drug : AD-2022 Drug : AD-2021 Placebo Drug : AD-2022 Placebo Phase : Phase 3
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Subjects with hypertension and hyperlipidemia
Exclusion Criteria
- •Patient with known or suspected secondary hypertension
- •Other exclusions applied
Arms & Interventions
Active Comparator 2
AD-2022, AD-2021 placebo
Intervention: AD-2022
Active Comparator 2
AD-2022, AD-2021 placebo
Intervention: AD-2021 Placebo
Active Comparator 1
AD-2021, AD-2022 placebo
Intervention: AD-2021
Active Comparator 1
AD-2021, AD-2022 placebo
Intervention: AD-2022 Placebo
Experimental 1
AD-2021, AD-2022
Intervention: AD-2021
Experimental 1
AD-2021, AD-2022
Intervention: AD-2022
Outcomes
Primary Outcomes
Low density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline, Week 8
LDL-C change at Week 8 compared AD-2021 + AD-2022 with AD-2022
Mean sitting systolic blood pressure (MSSBP)
Time Frame: Baseline, Week 8
MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021