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

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: NCT03872232
Recruitment Status : Active, not recruiting
First Posted : March 13, 2019
Last Update Posted : March 14, 2019
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 in patients with primary hypercholesterolemia and essential hypertension.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Hypertension Drug: Ezetimibe/Rosuvastatin Drug: Telmisartan 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 26, 2019
Estimated Primary Completion Date : December 12, 2019
Estimated Study Completion Date : December 12, 2019


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 Name: Rosuvamibe Tab.

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




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

  2. Mean sitting systolic blood pressure (MSSBP) [ Time Frame: Baseline, Week 8 ]
    MSSBP change at Week 8 compared to Baseline


Secondary Outcome Measures :
  1. Mean sitting systolic blood pressure (MSSBP) [ Time Frame: Baseline, Week 4 ]
    MSSBP change at Week 4 compared to Baseline

  2. Low density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline, Week 4 ]
    LDL-C change at Week 4 compared to Baseline

  3. Mean sitting diastolic blood pressure (MSDBP) [ Time Frame: Baseline, Week 4, Week 8 ]
    MSDBP change at Week 4, 8 compared to Baseline

  4. Total Cholesterol (TC) [ Time Frame: Baseline, Week 4, Week 8 ]
    TC change at Week 4, 8 compared to Baseline

  5. High density lipoprotein cholesterol (HDL-C) [ Time Frame: Baseline, Week 4, Week 8 ]
    HDL-C change at Week 4, 8 compared to Baseline

  6. Triglyceride (TG) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline, Week 4, Week 8 ]
    TC/HDL-C change at Week 4,8 compared to Baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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): NCT03872232


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
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: NCT03872232    
Other Study ID Numbers: ROZETEL_RCT
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: February 2019
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
Telmisartan
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists