Dyslipidemias, Hypertension
Conditions
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.
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
DRUGNEWSTATIN 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
DRUGCADUET
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
Sponsors
Hyo-Soo Kim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent changes in mean sitting systolic blood pressure (MSSBP) | 8 weeks | Percent changes in MSSBP from baseline after 8 weeks of treatment |
| Percent changes in LDL-C | 8 weeks | Percent changes in LDL-C from baseline after 8 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent changes in LDL-C | 4 weeks | Percent changes in LDL-C from baseline after 4 weeks of treatment |
| Percent changes in TC | 4, 8weeks | Percent changes in TC from baseline after 4 and 8 weeks of treatment |
| Percent changes in TG | 4, 8weeks | Percent changes in TG from baseline after 4 and 8 weeks of treatment |
| Percent changes in HDL-C | 4, 8weeks | Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment |
| Percent changes in Non-HDL-C | 4, 8weeks | Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement |
| Percent changes in Apo B | 4, 8weeks | Percent changes in Apo B from baseline after 4 and 8 weeks of treatment |
| Percent changes in Apo A-I | 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 | 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 | 4, 8weeks | Percent changes in Apo B/Apo A-I from baseline after 4 and 8 weeks of treatment |
| Percent changes in hs-CRP | 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 | 8 weeks | The percentage of patients achieving treatment goal for blood pressure and LDL-C |
| Changes in mean sitting systolic/diastolic blood pressure | 4, 8weeks | Changes in mean sitting systolic/diastolic blood pressure after 4 and 8 weeks of treatment |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORHyo-Soo Kim
Seoul National University Hospital
Outcome results
None listed