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Completed

NCT Number: NCT03860220

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias 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 4

Primary location

Kangwon National University Hospital, Chuncheon, Gangwon-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Newstatin TS 40/5/10mg

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

Other names: Caduet 5/10mg

Primary outcomes

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

    Time frame: 8 weeks

    Percent changes in MSSBP from baseline after 8 weeks of treatment

  2. Percent changes in LDL-C

    Time frame: 8 weeks

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

Secondary outcomes

  1. Percent changes in LDL-C

    Time frame: 4 weeks

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

  2. Percent changes in TC

    Time frame: 4, 8weeks

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

  3. Percent changes in TG

    Time frame: 4, 8weeks

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

  4. Percent changes in HDL-C

    Time frame: 4, 8weeks

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

  5. Percent changes in Non-HDL-C

    Time frame: 4, 8weeks

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

  6. Percent changes in Apo B

    Time frame: 4, 8weeks

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

  7. Percent changes in Apo A-I

    Time frame: 4, 8weeks

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

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

    Time frame: 4, 8weeks

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

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

    Time frame: 4, 8weeks

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

  10. Percent changes in hs-CRP

    Time frame: 4, 8weeks

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

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

    Time frame: 8 weeks

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

  12. Changes in mean sitting systolic/diastolic blood pressure

    Time frame: 4, 8weeks

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

Sponsors and collaborators

Lead sponsor

Hyo-Soo Kim

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2019
Registry last updated
Apr 27, 2026

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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