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Completed

NCT Number: NCT03872232

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

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.

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Key information

Conditions

Hypercholesterolemia Cardiovascular Diseases Dyslipidemias Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Subjects with hypertension and hyperlipidemia

Exclusion criteria

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

Treatment and study plan

Ezetimibe/Rosuvastatin

Drug

PO, Once daily(QD), 8weeks

Other names: Rosuvamibe Tab.

Telmisartan

Drug

PO, Once daily(QD), 8weeks

Other names: Micardis Tab.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2019
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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