S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension
NCT ID: NCT03226340
Last Updated: 2017-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
170 participants
INTERVENTIONAL
2015-12-02
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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S-amlodipine + Chlorthalidone
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
S-amlodipine 2.5mg + Chlorthalidone 25mg
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
S-amlodipine + Telmisartan
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.
S-amlodipine 2.5mg + Telmisartan 40mg
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.
Interventions
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S-amlodipine 2.5mg + Chlorthalidone 25mg
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
S-amlodipine 2.5mg + Telmisartan 40mg
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
79 Years
ALL
No
Sponsors
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Hanlim Pharm. Co., Ltd.
INDUSTRY
Seoul National University Bundang Hospital
OTHER
Responsible Party
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Dong-Ju Choi
Professor, MD, PhD
Locations
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Hallym University Medical Center
Anyang, Dongan-gu, South Korea
Kyung Hee University Hospital
Seoul, Dongdaemun-gu, South Korea
Hallym University Medical Center
Seoul, Gangdong-gu,, South Korea
Samsung Medical Center
Seoul, Gangnam-Gu, South Korea
Korea Univ. Guro Hospital
Seoul, Guro, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Hanyang University Medical Center
Seoul, Seongdong-gu, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Ajou Univ. Medical Center
Suwon, Yeong-tong, South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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HL_LDN_504
Identifier Type: -
Identifier Source: org_study_id
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