Clinical trial NCT03860220: The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Dyslipidemias
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 304
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent changes in mean sitting systolic blood pressure (MSSBP)
timeFrame: 8 weeks
measure: Percent changes in LDL-C
timeFrame: 8 weeks
Secondary outcomes:
measure: Percent changes in LDL-C
timeFrame: 4 weeks
measure: Percent changes in TC
timeFrame: 4, 8weeks
measure: Percent changes in TG
timeFrame: 4, 8weeks
measure: Percent changes in HDL-C
timeFrame: 4, 8weeks
measure: Percent changes in Non-HDL-C
timeFrame: 4, 8weeks
measure: Percent changes in Apo B
timeFrame: 4, 8weeks
measure: Percent changes in Apo A-I
timeFrame: 4, 8weeks
measure: Percent changes in LDL-C/HDL-C ratio
timeFrame: 4, 8weeks
measure: Percent changes in Apo B/Apo A-I ratio
timeFrame: 4, 8weeks
measure: Percent changes in hs-CRP
timeFrame: 4, 8weeks
measure: The percentage of patients achieving treatment goal for blood pressure and LDL-C
timeFrame: 8 weeks
measure: Changes in mean sitting systolic/diastolic blood pressure
timeFrame: 4, 8weeks
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References: