Trial Condition(s):
Controlled Release Nifedipine and Valsartan Combination Therapy in Patients with Essential Hypertension
11518
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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.
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
- 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.
Locations | |
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Locations Shinjuku Oak Tower Clinic Shinjuku-ku, Japan, 163-6003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hiraoka Medical Clinic Hiroshima, Japan, 733-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tomita Medical Clinic Internal/Cardiovascular Medicine Sapporo, Japan, 060-0003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yoga Allergy Clinic Setagaya-ku, Japan, 158-0097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Clinical effect and cost effectiveness of Ca antagonist in combination with AII receptor antagonist in patient with essential hypertension (PMS study)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2