Clincosm LogoSign in Get a demo

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

Sponsor
Addpharma Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03872232
Collaborator
(none)
180
Enrollment
1
Location
3
Arms
17.5
Actual Duration (Months)
10.3
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 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 in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Rosuvastatin/Ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe" for 8 weeks.

In "Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Telmisartan" for 8 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan in Patients With Primary Hypercholesterolemia and Essential Hypertension
Actual Study Start Date :
Feb 26, 2019
Actual Primary Completion Date :
Aug 12, 2020
Actual Study Completion Date :
Aug 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ezetimibe/Rosuvastatin and Telmisartan

60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and 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: Ezetimibe/Rosuvastatin

    60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks.

    Drug: Ezetimibe/Rosuvastatin
    PO, Once daily(QD), 8weeks
    Other Names:
  • Rosuvamibe Tab.

    		•
    Active Comparator: Telmisartan

    60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks.

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

      LDL-C change at Week 8 compared to Baseline

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

      MSSBP change at Week 8 compared to Baseline

    Secondary Outcome Measures

    1. Mean sitting systolic blood pressure (MSSBP) [Baseline, Week 4]

      MSSBP change at Week 4 compared to Baseline

    2. Low density lipoprotein cholesterol (LDL-C) [Baseline, Week 4]

      LDL-C change at Week 4 compared to Baseline

    3. Mean sitting diastolic blood pressure (MSDBP) [Baseline, Week 4, Week 8]

      MSDBP change at Week 4, 8 compared to Baseline

    4. Total Cholesterol (TC) [Baseline, Week 4, Week 8]

      TC change at Week 4, 8 compared to Baseline

    5. High density lipoprotein cholesterol (HDL-C) [Baseline, Week 4, Week 8]

      HDL-C change at Week 4, 8 compared to Baseline

    6. Triglyceride (TG) [Baseline, Week 4, Week 8]

      TG change at Week 4, 8 compared to Baseline

    7. Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C) [Baseline, Week 4, Week 8]

      LDL-C/HDL-C change at Week 4, 8 compared to Baseline

    8. Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C) [Baseline, Week 4, Week 8]

      TC/HDL-C change at Week 4,8 compared to Baseline

    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 03080

    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:
    NCT03872232
    Other Study ID Numbers:
    • ROZETEL_RCT
    First Posted:
    Mar 13, 2019
    Last Update Posted:
    Jan 15, 2021
    Last Verified:
    Jan 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
    Telmisartan
    Rosuvastatin Calcium
    Ezetimibe

    Study Results

    No Results Posted as of Jan 15, 2021