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NCT04158076 Clinical Trial

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

Hypertension Clinical Trial

Official title:
A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04158076
Other study ID # ROZETELA RCT
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 23, 2020
Est. completion date January 14, 2021

Study information
Verified date May 2021
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 131
Est. completion date January 14, 2021
Est. primary completion date January 14, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Signed informed consent - Subjects with hypertension and hyperlipidemia Exclusion Criteria: - Patient with known or suspected secondary hypertension - Other exclusions applied

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ezetimibe/Rosuvastatin
PO, Once daily(QD), 8weeks
• Telmisartan
PO, Once daily(QD), 8weeks
• Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET
PO, Once daily(QD), 8weeks

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Low density lipoprotein cholesterol (LDL-C) LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073 Baseline, Week 8
Primary Mean sitting systolic blood pressure (MSSBP) MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073 Baseline, Week 8
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