Hypertension
Conditions
Brief summary
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.
Interventions
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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: * SBP\>/=160mmHg or DBP\>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure) * SBP\>/=150mmHg or DBP\>/=95mmHg for patients with previous treatment by antihypertensive agents
Exclusion criteria
* Patients whose blood pressure on either day of Visit 1 or 2 is: SBP \> 200mmHg or DBP \> 120mmHg. * Patients with secondary hypertension or hypertensive emergency such as malignant hypertension. * Patients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study. * Patients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study. * Patients with uncontrolled diabetes (HbA1c \>/=8%) * Patients with bradycardia or tachycardia (\<50 bpm, \>/=100 bpm), arrhythmia such as atrioventricular block (second and third degree), sinoatrial block or atrial fibrillation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean treatment cost* for 16-week of double-blind treatment period | 16 weeks | \* Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores. |
| Proportion of participants** achieving target blood pressure at the end of double-blind treatment period | at week 16 | \*\*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) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants for each age group to target blood pressure level | at week 16 |
| 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 |
| Safety variables will be summarized using descriptive statistics based on adverse events collections | 16 weeks |
| Incidence of treatment-emergent drug-related adverse events | 16 weeks |
| The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) . | baseline to week 16 |
Countries
Japan
Outcome results
None listed