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The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients.
To investigate incremental cost effectiveness, primary variables are mean treatment cost and achievement rate to target blood pressure level at the end of double-blind treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Adalat CR 20-40mg od + Diovan 40-80mg od |
|
| Arm 2 | Active Comparator | Norvasc 2.5-5mg od + Diovan 40-80mg od |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine (Adalat, BAYA1040) | Drug |
| ||
| Amlodipine (Norvasc) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean treatment cost* for 16-week of double-blind treatment period | * Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores. | 16 weeks |
| Proportion of participants** achieving target blood pressure at the end of double-blind treatment period | **For subjects aged under 60 years: SBP<130mmHg and DBP<85mmHg, for subjects aged 60 years or over: SBP<140mmHg and DBP<90mmHg (SBP Systolic blood pressure, DBP Diastolic blood pressure) | at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment cost per subject to achieve the target blood pressure (Total costs for the double-blind treatment period / Number of patients who achieve the target blood pressure at the end of double-blind treatment period) | 16 weeks | |
| The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) . |
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Inclusion Criteria:
Untreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hiroshima | Hiroshima | 733-0011 | Japan | |||
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| D017311 | Amlodipine |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Diovan | Drug |
|
| baseline to week 16 |
| Proportion of participants for each age group to target blood pressure level | at week 16 |
| Incidence of treatment-emergent drug-related adverse events | 16 weeks |
| Safety variables will be summarized using descriptive statistics based on adverse events collections | 16 weeks |
| Sapporo |
| Hokkaido |
| 060-0003 |
| Japan |
| Setagaya-ku | Tokyo | 158-0097 | Japan |
| Shinjuku-ku | Tokyo | 163-6003 | Japan |
| D013777 |
| Tetrazoles |
| D001393 | Azoles |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |