Status:
UNKNOWN
The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin
Lead Sponsor:
Hyo-Soo Kim
Conditions:
Hypertension
Dyslipidemias
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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 dys...
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). Aft...
Eligibility Criteria
Inclusion
- 145 mmHg ≤ msSBP ≤ 190 mmHg
- Triglycerides \< 500 mg/dL
- LDL-C ≤ 250 mg/dL
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT03860220
Start Date
March 1 2019
End Date
June 1 2020
Last Update
March 1 2019
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