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Completed

NCT Number: NCT03067688

Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia

Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias 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 Natuional University Hospital

Seoul, Jongno, 03080, South Korea

About this study

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.

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

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

In "Temisartan/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Rosuvastatin" 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

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

Treatment and study plan

Temisartan+Amlodipine+Rosuvastatin (Combination drug)

Drug

PO, Once daily(QD), 8weeks

Other names: Twynsta Tab.+Crestor Tab.

Temisartan+Amlodipine

Drug

PO, Once daily(QD), 8weeks

Other names: Twynsta Tab.

Temisartan+Rosuvastatin

Drug

PO, Once daily(QD), 8weeks

Other names: Micardis Tab.+Crestor Tab.

Primary outcomes

  1. Mean sitting systolic blood pressure (MSSBP)

    Time frame: Baseline, Week 8

    MSSBP change form the baseline at Week 8

  2. Low density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline, Week 8

    LDL-C change form the baseline at Week 8

Secondary outcomes

  1. MSSBP (Mean sitting systolic blood pressure)

    Time frame: Baseline, Week 4

    MSSBP change form the baseline at Week 4

  2. Mean sitting diastolic blood pressure (MSDBP)

    Time frame: Baseline, Week 4, Week 8

    MSDBP change form the baseline at Week 4, 8

  3. Low density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline, Week 4

    LDL-C change form the baseline at Week 4

  4. Total Cholesterol (TC)

    Time frame: Baseline, Week 4, Week 8

    TC change form the baseline at Week 4, 8

  5. High density lipoprotein cholesterol (HDL-C)

    Time frame: Baseline, Week 4, Week 8

    HDL-C change form the baseline at Week 4, 8

  6. Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)

    Time frame: Baseline, Week 4, Week 8

    LDL-C/HDL-C change form the baseline at Week 4, 8

  7. Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)

    Time frame: Baseline, Week 4, Week 8

    TC/HDL-C change form the baseline at Week 4, 8

  8. Triglyceride (TG)

    Time frame: Baseline, Week 4, Week 8

    TG change form the baseline at Week 4, 8

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Temisartan/Amlodipine and Rosuvastatin in Subjects With Hypertension and Hyperlipidemia

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2017
Registry last updated
Jan 16, 2019

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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