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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