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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158076
Recruitment Status : Active, not recruiting
First Posted : November 8, 2019
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Hypertension Drug: Ezetimibe/Rosuvastatin Drug: Telmisartan Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : January 18, 2021
Estimated Study Completion Date : January 18, 2021


Arm Intervention/treatment
Experimental: Co-administered of AD-2071 and AD-2073
48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
Drug: Ezetimibe/Rosuvastatin
PO, Once daily(QD), 8weeks
Other Name: Rosuvamibe Tab.

Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET
PO, Once daily(QD), 8weeks
Other Name: Twynsta

Active Comparator: Co-administered of AD-2071 and AD-2072
48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.
Drug: Ezetimibe/Rosuvastatin
PO, Once daily(QD), 8weeks
Other Name: Rosuvamibe Tab.

Drug: Telmisartan
PO, Once daily(QD), 8weeks
Other Name: Micardis Tab.

Active Comparator: AD-2073
48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET
PO, Once daily(QD), 8weeks
Other Name: Twynsta




Primary Outcome Measures :
  1. Low density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline, Week 8 ]
    LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073

  2. Mean sitting systolic blood pressure (MSSBP) [ Time Frame: Baseline, Week 8 ]
    MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158076


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Addpharma Inc.
Investigators
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Principal Investigator: Hyo Soo Kim, M.D., Ph.D Seoul National University Hospital
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Responsible Party: Addpharma Inc.
ClinicalTrials.gov Identifier: NCT04158076    
Other Study ID Numbers: ROZETELA RCT
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Hypercholesterolemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Telmisartan
Telmisartan amlodipine combination
Rosuvastatin Calcium
Ezetimibe
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists