S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03226340

Collaborator

Hanlim Pharm. Co., Ltd. (Industry)

170

Enrollment

Locations

Arms

27.9

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: S-amlodipine 2.5mg + Chlorthalidone 25mg Drug: S-amlodipine 2.5mg + Telmisartan 40mg	Phase 4

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

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Actual Study Start Date :

Dec 2, 2015

Anticipated Primary Completion Date :

Mar 31, 2018

Anticipated Study Completion Date :

Mar 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S-amlodipine + Chlorthalidone patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.	Drug: S-amlodipine 2.5mg + Chlorthalidone 25mg patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
Active Comparator: S-amlodipine + Telmisartan patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.	Drug: S-amlodipine 2.5mg + Telmisartan 40mg patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.

Arm

Intervention/Treatment

Experimental: S-amlodipine + Chlorthalidone

patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.

Drug: S-amlodipine 2.5mg + Chlorthalidone 25mg

patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.

Active Comparator: S-amlodipine + Telmisartan

patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.

Drug: S-amlodipine 2.5mg + Telmisartan 40mg

patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.

Outcome Measures

Primary Outcome Measures

sit diastolic blood pressure [12 weeks]
Mean change in sit diastolic blood pressure after 12 weeks compared to baseline.

Secondary Outcome Measures

sit diastolic blood pressure [6 weeks]
Mean change in sit diastolic blood pressure after 6 weeks compared to baseline.
sit systolic blood pressure [12 weeks]
Mean change in sit systolic blood pressure after 6 weeks and 12 weeks compared to baseline.
Blood pressure normalization [12 weeks]
Blood pressure normalization ratio after 12 weeks compared to baseline( sit systolic blood pressure <140 mmHg or sit diastolic blood pressure <90 mmHg).

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hallym University Medical Center	Anyang	Dongan-gu	Korea, Republic of	14068
2	Kyung Hee University Hospital	Seoul	Dongdaemun-gu	Korea, Republic of	02447
3	Hallym University Medical Center	Seoul	Gangdong-gu,	Korea, Republic of	05355
4	Samsung Medical Center	Seoul	Gangnam-Gu	Korea, Republic of	06351
5	Korea Univ. Guro Hospital	Seoul	Guro	Korea, Republic of	08308
6	Seoul National University Hospital	Seoul	Jongno-gu	Korea, Republic of	03080
7	Hanyang University Medical Center	Seoul	Seongdong-gu	Korea, Republic of	04763
8	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	05505
9	Ajou Univ. Medical Center	Suwon-si	Yeong-tong	Korea, Republic of	16499
10	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of	463707