Olmesartan on Ambulatory Blood Pressure Change

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

We will conduct an open label, non-comparative, observational study to evaluate the efficacy, safety and tolerability of Olmesartan therapy in Taiwan patients with essential hypertension, and the primary objective is the change in the 24-hour mean systolic blood pressure from baseline to the day after post-treatment week-12 visit according to the ambulatory blood pressure monitoring.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Angiotensin Receptor Antagonists; Olmesartan; Olmesartan Medoxomil

Criteria

Inclusion Criteria:

• Male or female, 18 years of age or over.

• naïve patients with Stage I** or Stage II** (JNC VII) essential hypertension or patients uncontrolled on current hypotensive drug therapy (in cuff BP>140/90mm Hg)

• All selected patients must give their written informed consent before recording their personal data

Exclusion Criteria:

• Subject with secondary form of hypertension

• Subject is being treated or with unstable condition for disease of myocardial infarction, clinically decompensated congestive heart failure, angina pectoris, sick sinus syndrome, second or third degree atrioventricular block

• Subject with history of hypertensive encephalopathy, grade 3 or 4 hypertensive retinopathy within 3 months before entering this trial

• Subjects with a cerebrovascular accident within 6 months before entering this trial

• Subject with auto-immune disease

• Subject with uncontrolled endocrine diseases, such as Hyperthyroidism, Hypothyroidism, Hypercorticism and Hypocorticism

• Subject with confirmed evidence of renal impairment (creatinine > 1.5 x upper limit of normal)

• Subject with hyperkalemia with serum potassium > 5.5 meq/L

• Subject with terminal stage of malignant disease

• Subject with substance abuse history

• Subject with gastrointestinal disease which can interfere the absorption of the oral medications

• Subject with any contraindication to the use of angiotensin II receptor blocker or calcium channel blocker

• Subject is pregnant or lactating

• Premenopausal subjects not taking reliable methods for contraceptives

• Subject with any other serious disease considered by the investigator not in the condition to enter the trial

• Subject is not able to comply to the protocol requirements

• Subject participated investigational drug trial within 3 months before entering this study