The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin

NCT03860220 | Completed Phase 4 DMC

• 1 other identifier: STAROS
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this study was to assess the efficacy and safety of FDC therapy with triple therapy of Telmisartan 40 mg/Amlodipine 5 mg/Rosuvastatin 10mg in Korean patients with both hypertension and dyslipidemia.

Conditions

Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• Percent changes in mean sitting systolic blood pressure (MSSBP)

  Percent changes in MSSBP from baseline after 8 weeks of treatment

  8 weeks

• Percent changes in LDL-C

  Percent changes in LDL-C from baseline after 8 weeks of treatment

  8 weeks

Secondary Outcomes (12)

• Percent changes in LDL-C

  4 weeks

• Percent changes in TC

  4, 8weeks

• Percent changes in TG

  4, 8weeks

• Percent changes in HDL-C

  4, 8weeks

• Percent changes in Non-HDL-C

  4, 8weeks

Study Arms (2)

NEWSTATIN TS

ACTIVE COMPARATOR

Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg)

Drug: NEWSTATIN TS

CADUET

PLACEBO COMPARATOR

Dual therapy (Amlodipine + Atorvastatin 5/10mg)

Drug: CADUET

Interventions

NEWSTATIN TS DRUG

Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with triple therapy (Newstatin TS 40/5/10mg) ; 1 tab qd for 8 weeks

Also known as: Newstatin TS 40/5/10mg

NEWSTATIN TS

CADUET DRUG

Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with dual therapy (Caduet 5/10mg) ; 1 tab qd for 8 weeks

Also known as: Caduet 5/10mg

CADUET

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mmHg ≤ msSBP ≤ 190 mmHg
• Triglycerides \< 500 mg/dL
• LDL-C ≤ 250 mg/dL

You may not qualify if:

• sSBP ≥ 20mmHg and sDBP ≥ 10mmHg
• symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia
• history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (New York Heart Association functional class III and IV)
• hypersensitivity to telmisartan or rosuvastatin
• history of angioedema after treatment with angiotensin-converting enzyme inhibitors or ARBs; creatinine phosphokinase levels ≥3 times the upper limit of normal
• estimated glomerular filtration rate ≤30 mL/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal
• potassium levels \>5.5 mmol/L; or any diseases that could affect the results of the study.

Sponsors & Collaborators

• Hyo-Soo Kim: lead

Study Sites (9)

Kangwon National University Hospital

Chuncheon, Gangwon-do, 24289, South Korea

Location

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 15355, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Yeungnam University Hospital

Daegu, 42415, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

Related Publications (1)

• Park S, Hwang D, Kang J, Han JK, Yang HM, Park KW, Kang HJ, Koo BK, Cho JM, Cho BR, Ahn SG, Kang SM, Sung JH, Kim U, Lee N, Kim HS. Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients with Dyslipidemia and Hypertension: A Multicenter Randomized Clinical Trial. Curr Ther Res Clin Exp. 2024 Feb 1;100:100735. doi: 10.1016/j.curtheres.2024.100735. eCollection 2024.

  PMID: 38380420 RESULT

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Interventions

amlodipine, atorvastatin drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hyo-Soo Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Coronary Intervention & Transcatheter Aortic Valve Implantation

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: March 1, 2019
• Study Start: April 25, 2019
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

KR (9)