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

Sponsor
Addpharma Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04158076
Collaborator
(none)
131
Enrollment
1
Location
3
Arms
11.7
Actual Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Jan 23, 2020
Actual Primary Completion Date :
Jan 14, 2021
Actual Study Completion Date :
Jan 14, 2021

Arms and Interventions

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 Names:
  • Rosuvamibe Tab.

    • Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET
    PO, Once daily(QD), 8weeks
    Other Names:
  • 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 Names:
  • Rosuvamibe Tab.

    • Drug: Telmisartan
    PO, Once daily(QD), 8weeks
    Other Names:
  • 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 Names:
  • Twynsta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Low density lipoprotein cholesterol (LDL-C) [Baseline, Week 8]

      LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073

    2. Mean sitting systolic blood pressure (MSSBP) [Baseline, Week 8]

      MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Signed informed consent

    • Subjects with hypertension and hyperlipidemia

    Exclusion Criteria:

    • Patient with known or suspected secondary hypertension

    • Other exclusions applied

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Addpharma Inc.

    Investigators

    • Principal Investigator: Hyo Soo Kim, M.D., Ph.D, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Addpharma Inc.
    ClinicalTrials.gov Identifier:
    NCT04158076
    Other Study ID Numbers:
    • ROZETELA RCT
    First Posted:
    Nov 8, 2019
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Hypercholesterolemia
    Amlodipine
    Telmisartan
    Telmisartan amlodipine combination
    Rosuvastatin Calcium
    Ezetimibe

    Study Results

    No Results Posted as of May 12, 2021