Clinical trial NCT03226340: S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Essential Hypertension
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Hanlim Pharm. Co., Ltd.
First posted: 2017-07-21
Enrollment: 170
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Men and women with essential hypertension who were aged 19 years or older and younger than 80 years
2. Patients who have been treated with amlodipine or S-amlodipine monotherapy for more than 2 weeks immediately before visit 1 (screening)
3. Visit 1 (screening) reference mean blood pressure measured three times in the arm is greater than sit DBP 90 mmHg
4. Those who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

1. 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.)
2. Patients with a mean SBP of 200 mmHg or more or a sit DBP of 110 mmHg or more at visit 1.
3. 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.
4. An uncontrolled diabetic patient(HbA1c≥9.0%)
5. 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)
6. Patients who are expected to take antihypertensive drugs other than clinical drugs during the trial
7. Patients with orthostatic hypotension with symptoms
8. Patients with a history of malignant tumors including leukemia and lymphoma within the past 5 years
9. Patients with a history of autoimmune diseases such as chronic joint rheumatism and systemic lupus erythematosus
10. Those who have a history of hypersensitivity to the amlodipine nicotinate or other chlortalidone or telmisartan drug
11. 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
12. 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.)
13. Shock patient
14. Patients with clinical history of alcohol or substance abuse
15. 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.
16. If the tester judges that the participation in the clinical trial is not legal or mental character
17. Clinical studies with other clinical trial drugs within 4 weeks prior to screening patients with experience

Primary outcomes:
measure: sit diastolic blood pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: sit diastolic blood pressure
timeFrame: 6 weeks
measure: sit systolic blood pressure
timeFrame: 12 weeks
measure: Blood pressure normalization
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
state: Dongan-gu
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center
state: Gangdong-gu,
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-Gu
city: Seoul
country: Korea, Republic of
facility: Korea Univ. Guro Hospital
state: Guro
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
state: Seongdong-gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Suwon-si
country: Korea, Republic of
facility: Ajou Univ. Medical Center
state: Yeong-tong
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
citation: Jo SH, Park SJ, Kim EJ, Kim SJ, Cho HJ, Song JM, Shin J, Park JJ, Shin JH, Han KR, Choi DJ. S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial. Trials. 2018 Jun 20;19(1):324. doi: 10.1186/s13063-018-2636-1.