Clinical trial NCT01518855: Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension
Official title: Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 514
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean treatment cost* for 16-week of double-blind treatment period
timeFrame: 16 weeks
measure: Proportion of participants** achieving target blood pressure at the end of double-blind treatment period
timeFrame: at week 16
Secondary outcomes:
measure: 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)
timeFrame: 16 weeks
measure: The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .
timeFrame: baseline to week 16
measure: Proportion of participants for each age group to target blood pressure level
timeFrame: at week 16
measure: Incidence of treatment-emergent drug-related adverse events
timeFrame: 16 weeks
measure: Safety variables will be summarized using descriptive statistics based on adverse events collections
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Sapporo
country: Japan
state: Hokkaido
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Hiroshima
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: