Status:
COMPLETED
Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension
Lead Sponsor:
Bayer
Conditions:
Hypertension
Eligibility:
All Genders
20-79 years
Phase:
PHASE4
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT01518855
Start Date
March 1 2004
End Date
April 1 2005
Last Update
January 26 2012
Active Locations (4)
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1
Hiroshima, Hiroshima, Japan, 733-0011
2
Sapporo, Hokkaido, Japan, 060-0003
3
Setagaya-ku, Tokyo, Japan, 158-0097
4
Shinjuku-ku, Tokyo, Japan, 163-6003