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| Name | Class |
|---|---|
| Hanlim Pharm. Co., Ltd. | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-amlodipine + Chlorthalidone | Experimental | patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks. |
|
| S-amlodipine + Telmisartan | Active Comparator | patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-amlodipine 2.5mg + Chlorthalidone 25mg | Drug | patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| sit diastolic blood pressure | Mean change in sit diastolic blood pressure after 12 weeks compared to baseline. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| sit diastolic blood pressure | Mean change in sit diastolic blood pressure after 6 weeks compared to baseline. | 6 weeks |
| sit systolic blood pressure | Mean change in sit systolic blood pressure after 6 weeks and 12 weeks compared to baseline. |
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Inclusion Criteria:
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 1.
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)
Within the last 6 months, patients who have received the following diseases or treatments and whose clinical judgment is meaningful to the researcher
Shock patient
Patients with clinical history of alcohol or substance abuse
Patients with potential pregnancy or breastfeeding
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Medical Center | Recruiting | Anyang | Dongan-gu | 14068 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29925421 | Derived | 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. |
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| S-amlodipine 2.5mg + Telmisartan 40mg | Drug | patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks. |
|
| 12 weeks |
| Blood pressure normalization | Blood pressure normalization ratio after 12 weeks compared to baseline( sit systolic blood pressure <140 mmHg or sit diastolic blood pressure <90 mmHg). | 12 weeks |
| Kyung Hee University Hospital | Recruiting | Seoul | Dongdaemun-gu | 02447 | South Korea |
|
| Hallym University Medical Center | Recruiting | Seoul | Gangdong-gu, | 05355 | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | Gangnam-Gu | 06351 | South Korea |
|
| Korea Univ. Guro Hospital | Recruiting | Seoul | Guro | 08308 | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | Jongno-gu | 03080 | South Korea |
|
| Hanyang University Medical Center | Recruiting | Seoul | Seongdong-gu | 04763 | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | Songpa-gu | 05505 | South Korea |
|
| Ajou Univ. Medical Center | Recruiting | Suwon | Yeong-tong | 16499 | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | 463707 | South Korea |
|
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C542574 | levamlodipine |
| D002752 | Chlorthalidone |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001562 | Benzimidazoles |
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