Olmesartan on Ambulatory Blood Pressure Change

NCT00854763 | Unknown

• 1 other identifier: 20091036M
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Change in the 24-hour mean diastolic blood pressure from baseline to the day after post-treatment week-12 visit

  12 weeks

Study Arms (1)

Hypertension

Drug: olmesartan

Interventions

olmesartan DRUG

olmesartan

Hypertension

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 patients with hypertension who received an angiotensin receptor antagonist, Olmesartan, for 12 weeks' treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

olmesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kuo-Liong Chien, MD, PhD

  Institute of Preventive Medicine, College of Public Health, National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuo-Liong Chien, MD, PhD

CONTACT

+886-2-3366-8017; klchien@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2009
• First Posted: March 3, 2009
• Study Start: April 1, 2009
• Last Updated: March 3, 2009

Record last verified: 2009-02

Locations

TW (1)