Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine

Phase 3

Completed

• Conditions: Hypertension; Hypercholesterolemia
• Interventions: Drug: Ezetimibe/Rosuvastatin; Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET; Drug: Telmisartan

• Registration Number: NCT04158076
• Lead Sponsor: Addpharma Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

Detailed Description

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.

In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" for 8 weeks.

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-08
• Study Start: 2020-01-23
• Primary Completion: 2021-01-14
• Study Completion: 2021-01-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Signed informed consent
• Subjects with hypertension and hyperlipidemia

Exclusion Criteria

• Patient with known or suspected secondary hypertension
• Other exclusions applied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Co-administered of AD-2071 and AD-2073	Ezetimibe/Rosuvastatin	48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
Co-administered of AD-2071 and AD-2072	Ezetimibe/Rosuvastatin	48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.
Co-administered of AD-2071 and AD-2073	Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET	48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
AD-2073	Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET	48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
Co-administered of AD-2071 and AD-2072	Telmisartan	48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Low density lipoprotein cholesterol (LDL-C)	Baseline, Week 8	LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073
Mean sitting systolic blood pressure (MSSBP)	Baseline, Week 8	MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of