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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2020

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.

Interventions

  • Drug: NEWSTATIN TS
    • 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
  • Drug: CADUET
    • 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

Arms, Groups and Cohorts

  • Active Comparator: NEWSTATIN TS
    • Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg)
  • Placebo Comparator: CADUET
    • Dual therapy (Amlodipine + Atorvastatin 5/10mg)

Clinical Trial Outcome Measures

Primary Measures

  • Percent changes in mean sitting systolic blood pressure (MSSBP)
    • Time Frame: 8 weeks
    • Percent changes in MSSBP from baseline after 8 weeks of treatment
  • Percent changes in LDL-C
    • Time Frame: 8 weeks
    • Percent changes in LDL-C from baseline after 8 weeks of treatment

Secondary Measures

  • Percent changes in LDL-C
    • Time Frame: 4 weeks
    • Percent changes in LDL-C from baseline after 4 weeks of treatment
  • Percent changes in TC
    • Time Frame: 4, 8weeks
    • Percent changes in TC from baseline after 4 and 8 weeks of treatment
  • Percent changes in TG
    • Time Frame: 4, 8weeks
    • Percent changes in TG from baseline after 4 and 8 weeks of treatment
  • Percent changes in HDL-C
    • Time Frame: 4, 8weeks
    • Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment
  • 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
  • Percent changes in Apo B
    • Time Frame: 4, 8weeks
    • Percent changes in Apo B from baseline after 4 and 8 weeks of treatment
  • 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
  • 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
  • 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
  • Percent changes in hs-CRP
    • Time Frame: 4, 8weeks
    • Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment
  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hyo-Soo Kim
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Hyo-Soo Kim, Director, Coronary Intervention & Transcatheter Aortic Valve Implantation – Seoul National University Hospital
  • Overall Official(s)
    • Hyo-Soo Kim, Principal Investigator, Seoul National University Hospital
  • Overall Contact(s)
    • Hak Seung Lee, 82-10-3166-8399, cardiolee@gmail.com

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