Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin

A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension

To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia With Hypertension
• Intervention / Treatment: Drug: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg); Drug: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo); Drug: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Pusan, Korea, Republic of
    • Inje university Haeundae Paik Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of
    • Kyunghee University Hospital at Gangdong
  • Seoul, Korea, Republic of
    • Soonchunhyang University Hospital, Seoul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Dyslipidemia with hypertesion
• msSBP < 180 mmHg
• msDBP < 110 mmHg
• LDL-C ≤ 250 mg/dL
• Triglycerides < 400 mg/dL

Exclusion Criteria:

• At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg
• CK normal range ≥ 2 times
• Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
• AST or ALT ≥ 2 times
• Uncontrolled diabetes mellitus (HbA1c≥9%)
• CLcr < 30 mL/min/1.73m^2
• K > 5.5 mEq/L
• Other exclusion applied

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin 20 mg for 8 weeks	Drug: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg); Twinstar(80/10 mg) and Rosuvastatin 20 mg for 8 weeks
Active Comparator: Group II; Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo for 8 weeks	Drug: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo); Twinstar(80/10 mg) and Rosuvastatin placebo for 8 weeks
Active Comparator: Group III; Treatment of Telmisartan 80 mg, Amodipine placebo, Rosuvastatin 20 mg for 8 weeks	Drug: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg); Twinstar placebo, Amlodipine 10 mg and Rosuvastatin 20 mg for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of LDL-C	baseline and 8 weeks
change of msSBP	baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• Hong SJ, Jeong HS, Cho JM, Chang K, Pyun WB, Ahn Y, Hyon MS, Kang WC, Lee JH, Kim HS. Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial. Clin Ther. 2019 Feb;41(2):233-248.e9. doi: 10.1016/j.clinthera.2018.12.008. Epub 2019 Jan 18.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): December 4, 2017

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Rosuvastatin Calcium; Telmisartan
• Other Study ID Numbers: J-TAROS-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No