NCT03226340UnknownPhase 4
Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With Calcium Channel Blocker Monotherapy
Seoul National University Bundang Hospital9 sites in 1 country170 target enrollmentStarted: December 2, 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 170
- Locations
- 9
- Primary Endpoint
- sit diastolic blood pressure
Study Overview
Brief Summary
Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With CCB(Calcium Channel Blocker) Monotherapy
Detailed Description
The aim of this study is to verify the difference at week 12 from the baseline value in the average variation of diastolic blood pressure (sitDBP) of the study group in which S-amlodipine / Chlorthalidone combination therapy is to be used in patients with essential hypertension who did not adequately respond to monotherapy of amlodipine or S-amlodipine, compared to the control group, in which a combination therapy of S-amlodipine / telmisartan is to be used.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women with essential hypertension who were aged 19 years or older and younger than 80 years
- •Patients who have been treated with amlodipine or S-amlodipine monotherapy for more than 2 weeks immediately before visit 1 (screening)
- •Visit 1 (screening) reference mean blood pressure measured three times in the arm is greater than sit DBP 90 mmHg
- •Those who have voluntarily agreed in writing to participate in the trial
Exclusion Criteria
- •Patients with a history of secondary hypertension and all those with suspected secondary hypertension (including, but not limited to, coarctation of the aorta, primary aldosteronism, renal artery stenosis, Cushing's syndrome, chromium-rich cell tumor, polycystic kidney disease, etc.)
- •Patients with a mean SBP of 200 mmHg or more or a sit DBP of 110 mmHg or more at visit
- •When the blood pressure was measured three times in the reference arm of visit 1 (screening), the difference between the highest lowest sit SBP was 20 mmHg or higher and the difference between the highest lowest sit DBP was 10 mmHg or higher.
- •An uncontrolled diabetic patient(HbA1c≥9.0%)
- •In addition to antihypertensive drugs, drugs that may affect blood pressure( Systemic steroids, Thyroid hormones, Oral contraceptives, antipsychotic drugs, NSAIDs, sympathomimetics, immunosuppressants, etc.) have been continuously administered for more than 12 weeks prior to visit 1 (screening)
- •Patients who are expected to take antihypertensive drugs other than clinical drugs during the trial
- •Patients with orthostatic hypotension with symptoms
- •Patients with a history of malignant tumors including leukemia and lymphoma within the past 5 years
- •Patients with a history of autoimmune diseases such as chronic joint rheumatism and systemic lupus erythematosus
- •Those who have a history of hypersensitivity to the amlodipine nicotinate or other chlortalidone or telmisartan drug
- •Patients with clinically significant renal • hepatic disease such as those on dialysis, cirrhosis, biliary obstruction, hepatic failure, or those who have the following findings on visit 1 (screening)
- •ALanine Transaminase or ASpartate Transaminase is more than 3 times the normal upper limit
- •Total bilirubin more than twice the normal upper limit
- •More than twice the Blood Urea Nitrogen normal upper limit
- •Alkaline Phosphatase More than twice the normal upper limit - Creatinine Clearance Less than 10 mL / min
- •Within the last 6 months, patients who have received the following diseases or treatments and whose clinical judgment is meaningful to the researcher
- •Severe heart disease (heart failure New York Heart Association class III and IV), ischemic heart disease, peripheral vascular disease, hemodynamically significant valve stenosis, arrhythmia, etc
- •Patients with severe cerebrovascular disorders (stroke, cerebral infarction, cerebral hemorrhage, etc.)
- •Shock patient
- •Patients with clinical history of alcohol or substance abuse
- •Patients with potential pregnancy or breastfeeding
- •In the case of pregnant women, if the negative is not confirmed during pregnancy test
- •Women who did not consent to contraception in a medically acceptable way during the trial
- •Medically acceptable contraceptive methods: use condoms, injectable or injectable contraceptives, intrauterine contraceptive device, etc.
- •If the tester judges that the participation in the clinical trial is not legal or mental character
- •Clinical studies with other clinical trial drugs within 4 weeks prior to screening patients with experience
Arms & Interventions
S-amlodipine + Chlorthalidone
Experimental
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
Intervention: S-amlodipine 2.5mg + Chlorthalidone 25mg (Drug)
S-amlodipine + Telmisartan
Active Comparator
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.
Intervention: S-amlodipine 2.5mg + Telmisartan 40mg (Drug)
Outcomes
Primary Outcomes
sit diastolic blood pressure
Time Frame: 12 weeks
Mean change in sit diastolic blood pressure after 12 weeks compared to baseline.
Secondary Outcomes
- sit diastolic blood pressure(6 weeks)
- sit systolic blood pressure(12 weeks)
- Blood pressure normalization(12 weeks)
Investigators
Dong-Ju Choi
Professor, MD, PhD
Seoul National University Bundang Hospital
Study Sites (9)
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