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HypertensionPhase 4NCT03860220

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

A Phase 4 study testing NEWSTATIN TS and CADUET in people with Hypertension and Dyslipidemias, run by Hyo-Soo Kim at 9 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hypertension, Dyslipidemias
What is being tested?
NEWSTATIN TS and CADUET
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
9 sitesSouth Korea
Study dates
25 Apr 2019to 7 Sep 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do, 15355

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do, 24289

  • Yeungnam University Hospital

    Daegu, 42415

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul

  • Kyung Hee University Hospital at Gangdong

    Seoul

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Parallel Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension

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.

Read the detailed description

Patients were randomly assigned to 2 groups: (1) Triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) Dual therapy (5mg of amlodipine and 10mg of atorvastatin). After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and the percent change in LDL-C between 2 group, will be compared.

Being tested
NEWSTATIN TS, CADUET
Medical subject headings
Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEWSTATIN TSDrug

    Also called Newstatin TS 40/5/10mg

    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

  • CADUETDrug

    Also called Caduet 5/10mg

    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

Study groups in NCT03860220
Study groupRoleWhat they receive
NEWSTATIN TSActive comparatorTriple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg)
Receives: Drug: NEWSTATIN TS
CADUETPlacebo comparatorDual therapy (Amlodipine + Atorvastatin 5/10mg)
Receives: Drug: CADUET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent changes in mean sitting systolic blood pressure (MSSBP)

    Percent changes in MSSBP from baseline after 8 weeks of treatment

    Measured: 8 weeks

  2. Percent changes in LDL-C

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

    Measured: 8 weeks

Secondary outcomes (12)

  1. Percent changes in LDL-C

    Percent changes in LDL-C from baseline after 4 weeks of treatment

    Measured: 4 weeks

  2. Percent changes in TC

    Percent changes in TC from baseline after 4 and 8 weeks of treatment

    Measured: 4, 8weeks

  3. Percent changes in TG

    Percent changes in TG from baseline after 4 and 8 weeks of treatment

    Measured: 4, 8weeks

  4. Percent changes in HDL-C

    Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment

    Measured: 4, 8weeks

  5. Percent changes in Non-HDL-C

    Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement

    Measured: 4, 8weeks

  6. Percent changes in Apo B

    Percent changes in Apo B from baseline after 4 and 8 weeks of treatment

    Measured: 4, 8weeks

  7. Percent changes in Apo A-I

    Percent changes in Apo A-I from baseline after 4 and 8 weeks of treatment

    Measured: 4, 8weeks

  8. Percent changes in LDL-C/HDL-C ratio

    Percent changes in LDL-C/HDL-C from baseline after 4 and 8 weeks of treatement

    Measured: 4, 8weeks

  9. Percent changes in Apo B/Apo A-I ratio

    Percent changes in Apo B/Apo A-I from baseline after 4 and 8 weeks of treatment

    Measured: 4, 8weeks

  10. Percent changes in hs-CRP

    Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment

    Measured: 4, 8weeks

  11. The percentage of patients achieving treatment goal for blood pressure and LDL-C

    The percentage of patients achieving treatment goal for blood pressure and LDL-C

    Measured: 8 weeks

  12. Changes in mean sitting systolic/diastolic blood pressure

    Changes in mean sitting systolic/diastolic blood pressure after 4 and 8 weeks of treatment

    Measured: 4, 8weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start25 Apr 2019
  3. Primary completion7 Sep 2023
  4. Study completion7 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03860220
Sponsor's protocol ID
STAROS
Status last verified
Apr 2026
First submitted
14 Jan 2019
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38380420

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NEWSTATIN TS and CADUET in people with Hypertension and Dyslipidemias, run by Hyo-Soo Kim at 9 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent changes in mean sitting systolic blood pressure (MSSBP) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03860220, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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