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To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine (Adalat, BAYA1040) and Valsartan | Drug | Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central systolic blood pressure | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in central diastolic blood pressure and pulse pressure | Week 4,8 | |
| Change in central systolic blood pressure | Week 4 | |
| Change in brachial systolic blood pressure and diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goyang | Gyeonggido | 410-773 | South Korea | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26996246 | Derived | Park JB, Shin JH, Kim DS, Youn HJ, Park SW, Shim WJ, Park CG, Kim DW, Lee HY, Choi DJ, Rim SJ, Lee SY, Kim JH; FOCUS Investigators. Safety of the Up-titration of Nifedipine GITS and Valsartan or Low-dose Combination in Uncontrolled Hypertension: the FOCUS Study. Clin Ther. 2016 Apr;38(4):832-42. doi: 10.1016/j.clinthera.2016.02.025. Epub 2016 Mar 17. |
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| Nifedipine (Adalat, BAYA1040) | Drug | Nifedipine 60mg, Once daily |
|
| Valsartan | Drug | Valsartan 160mg, Once daily |
|
| Week 4,8 |
| Change in brachial pulse pressure | Week4,8 |
| Change in augmentation index and augmentation pressure | Week 4,8 |
| Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP) | Week 4,8 |
| Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP | Week 4,8 |
| Goyang-si |
| Gyeonggido |
| 411-706 |
| South Korea |
| Chungchungbuk-do | Korea | 361-711 | South Korea |
| Seoul | Korea | 135-720 | South Korea |
| Seoul | Seoul Teugbyeolsi | 152-703 | South Korea |
| Busan | South Korea |
| Gwangju | 501-757 | South Korea |
| Joong-gu | 100-380 | South Korea |
| Kungki-do | 463-707 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 136-705 | South Korea |
| Seoul | 137-701 | South Korea |
| Suwan | 443-721 | South Korea |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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