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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00854763 |
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.
Condition | Intervention |
---|---|
Hypertension |
Drug: olmesartan |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Phase 4 Study on Olmesartan, an Angiotensin Receptor Blocker, on Ambulatory Blood Pressure Change, Vitamin D Levels and Urinary Sodium Excretion of Patients With Hypertension |
Estimated Enrollment: | 100 |
Study Start Date: | April 2009 |
Groups/Cohorts | Assigned Interventions |
---|---|
Hypertension |
Drug: olmesartan
olmesartan
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Vitamin D plays an important role for cardiac function and blood pressure regulation, and the serum 25(OH)D concentration change is an important indicator for Vitamin D nutritional status, and serum 1,25(OH)2D is an active hormone for biological actions. However, little is known about the change of vitamin D concentration was related to the usage of angiotensin receptor blocker among patients with hypertension.
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. Our second endpoints included:
The major aim of this proposal is to investigate the effect of angiotensin receptor blocker, Olmesartan, for a 12 weeks' treatment among patients with hypertension in the outpatient clinics in one hospital center. We set the blood pressure measured from ambulatory blood pressure monitor as the primary endpoint. Furthermore, we will test Vitamin D related concentrations and 24 hour urine sodium excretion change with the blood pressure change. We will recruit 200 patients with hypertension in this observational study and will evaluate the efficacy and safety issues among these patients. The specific aims of this proposal will include:
The unique feature of this proposal includes a well-designed observational study with experienced clinicians and epidemiologists to conduct the study.
Under the infrastructure in a tertiary hospital center, participant compliance, follow up, quality control and outcomes measurements can be assured and monitored under the guideline of good clinical practice. Furthermore, the investigators are the experts in vitamin D associated measurements and biomarkers studies and in clinical setting. This proposal will provide important scientific knowledge about the relationship among blood pressure change, vitamin D and urinary sodium excretion among hypertensive patients under 12 weeks' angiotensin receptor blocker treatment in Taiwan.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
200 patients with hypertension who received an angiotensin receptor antagonist, Olmesartan, for 12 weeks' treatment
Inclusion Criteria:
Exclusion Criteria:
Contact: Kuo-Liong Chien, MD, PhD | +886-2-3366-8017 | klchien@ntu.edu.tw |
Taiwan | |
National Taiwan University Hospital | |
Taipei, Taiwan, 100 |
Principal Investigator: | Kuo-Liong Chien, MD, PhD | Institute of Preventive Medicine, College of Public Health, National Taiwan University |
Responsible Party: | National Taiwan University Hospital ( National Taiwan University Hospital ) |
Study ID Numbers: | 20091036M |
Study First Received: | March 1, 2009 |
Last Updated: | March 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00854763 History of Changes |
Health Authority: | Taiwan: Department of Health |
Angiotensin II Type 1 Receptor Blockers Vitamin D Vitamins Vascular Diseases Olmesartan medoxomil |
Cardiovascular Agents Antihypertensive Agents Angiotensin II Hypertension |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Vascular Diseases Olmesartan medoxomil |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Hypertension |