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| ID | Type | Description | Link |
|---|---|---|---|
| ADVISE | Other Identifier | Company Internal |
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This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalat (Nifedipine, BAYA1040) | Drug | Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring | Baseline and 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP) | 8 and 12 weeks of treatment | |
| Control rate (</=140/90 of office BP) | 8 and 12 weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
Participation in any clinical investigational drug study within the previous 12 weeks
Concomitant treatments with:
Severe hypertension (DBP >/= 110 mm Hg and/or SBP >/= 180 mm Hg) and/or evidence of secondary forms of hypertension
Any of the following cardiovascular diseases:
History of cardiovascular shock
Myocardial infarction or unstable angina within the previous 6 months
Severe cardiac valve disease
Past or present severe rhythm or conduction disorder.
Cerebrovascular ischemic event and/or history of intracerebral hemorrhage or subarachnoid hemorrhage (SAH) within the previous 12 months
Type 1 or 2 diabetes mellitus
Proteinuria
Uncorrected hypokalemia or hyperkalemia, sodium depletion and/or hypovolemia
Gastrointestinal disease resulting in the potential for malabsorption and/or severe gastro-intestinal tract narrowing; kock pouch (ileostomy after proctocolectomy)
Cholestasis or biliary obstruction
Liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels >3 x upper limits of normal (ULN)
Renal failure, creatinine level >2.0 mg/dl
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou | Guangdong | 510080 | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23134522 | Derived | Ke YN, Dong YG, Ma SP, Yuan H, Ihm SH, Baek SH; ADVISE study group. Improved blood pressure control with nifedipine GITS/valsartan combination versus high-dose valsartan monotherapy in mild-to-moderate hypertensive patients from Asia: results from the ADVISE study, a randomized trial. Cardiovasc Ther. 2012 Dec;30(6):326-32. doi: 10.1111/1755-5922.12003. |
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| Diovan (Valsartan) |
| Drug |
Valsartan 160 mg OM (Two Valsartan 80mg tablets) |
|
| Change in pulse pressure (difference between SBP and DBP) |
| 12 weeks of treatment |
| Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria | Baseline and 12 weeks of treatment |
| Adverse Event reporting | At the start, every 4 weeks during treatment and at the end of treatment |
| Vitals signs | At the start, every 4 weeks during treatment and at the end of treatment |
| Laboratory tests | At the start and at the end of treatment |
| Shijiazhuang |
| Hebei |
| 050051 |
| China |
| Changsha | Hunan | 410008 | China |
| Changsha | Hunan | 410013 | China |
| Nanjing | Jiangsu | 210008 | China |
| Nanjing | Jiangsu | 210029 | China |
| Shenyang | Liaoning | 110001 | China |
| Beijing | 100029 | China |
| Beijing | 100037 | China |
| Shanghai | 200025 | China |
| Donggu | Gwangju Gwang''yeogsi | 501757 | South Korea |
| Bucheon-si | Gyeonggido | South Korea |
| Yangsan | Gyeongsangnam-do | South Korea |
| Jongno-gu | South Korea |
| Junggu | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | 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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