The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin (NCT03860220) | Clinical Trial Compass
CompletedPhase 4
The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin
South Korea252 participantsStarted 2019-04-25
Plain-language 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.
Who can participate
Age range19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percent changes in mean sitting systolic blood pressure (MSSBP)