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Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by Telmisartan/Amlodipine Combination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan/Amlodipine+Hydrochlorothiazide | Experimental | Telmisartan/Amlodipine combination drug and Hydrochlorothiazide |
|
| Telmisartan/Amlodipine | Active Comparator | Telmisartan/Amlodipine combination drug and Placebo for Hydrochlorothiazide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan/Amlodipine+Hydrochlorothiazide | Drug | Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg 1 Tab.QD |
| Measure | Description | Time Frame |
|---|---|---|
| The change of sitting systolic blood pressure | From baseline at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of sitting systolic blood pressure | From baseline at week 2 | |
| The change of sitting diastolic blood pressure | From baseline at week 2 and 8 | |
| The ratio of subjects who get normalized blood pressure |
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Inclusion Criteria:
19 years old or above Koreans living in Korea
Patients with uncontrolled essential hypertension at screening time(Visit 1)
Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2)
- 140 mmHg ≤ sitSBP < 200 mmHg
Patients who agreed to participate in the trial
Exclusion Criteria:
Test results showing the following values at screening time(Visit 1)
Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma)
-Patients with congestive heart failure(NYHA class III~IV)
Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c > 9%
Patients who have history of severe or malignant retinopathy within 6 months prior to study entry
Patients who suspected of Renal dysfunction that may affect the absorption, distribution, metabolism or excretion (Serum Creatinine :> 2mg/dL ), gastrointestinal, haematological, liver disease (AST or ALT > 2.5 times of upper limit of normal range)
Patients who should be administered antihypertensive drugs other than clinical trial medication(Diuretics, β-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, α-blockers, Renin Inhibitors, Vasodilators)
Patients who should be administered medications prohibited for concomitant use during study period
Patients who are dependent on drugs or alcohol
Patients with surgical and medical disease that may affect the absorption, distribution, metabolism or excretion
Patients with hypersensitivity to the components of investigational drug.
Patients with hypersensitivity to Sulfonamide
Patients with anuria
Patients with hypercalcemia, hyponatremia/hypokalemia
Patients with Addison's disease
Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Patients with any chronic or accute inflammation disease needed to chronic inflammation therapy
History of malignant tumor including leukemia, lymphoma within 5 years
Patients taking other clinical trial drugs within 30 days from the time of visit for screening
Pregnancy, breast-feeding, or child-bearing potential Patients
Patients who are judged unsuitable to participate in this study by investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29248384 | Derived | Sung KC, Oh YS, Cha DH, Hong SJ, Won KH, Yoo KD, Rha SW, Ahn YK, Ahn JC, Jang JY, Hong TJ, Cho SK, Park SH, Hyon MS, Nam CW, Chae IH, Yoo BS, Song JM, Jeong JO, Yoon YW, Kim BS, Yang TH, Cho DK, Kim SH, Choi YJ, Ahn JH, Jeon DW, Kim HS. Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine: The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study. Clin Ther. 2018 Jan;40(1):50-63.e3. doi: 10.1016/j.clinthera.2017.11.006. Epub 2017 Dec 14. |
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| Telmisartan/Amlodipine | Drug | Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg Placebo 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg Placebo 1 Tab.QD |
|
| Placebo for Hydrochlorothiazide | Drug |
|
| at week 2 and 8 |
| Response Rate | at week 2 and 8 |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| C548840 | telmisartan amlodipine combination |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
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