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Olmesartan on Ambulatory Blood Pressure Change

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ClinicalTrials.gov Identifier: NCT00854763
Recruitment Status : Unknown
Verified February 2009 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 3, 2009
Last Update Posted : March 3, 2009
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date March 1, 2009
First Posted Date March 3, 2009
Last Update Posted Date March 3, 2009
Study Start Date April 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: March 1, 2009)
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. [ Time Frame: 12 weeks ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 1, 2009)
Change in the 24-hour mean diastolic blood pressure from baseline to the day after post-treatment week-12 visit [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Olmesartan on Ambulatory Blood Pressure Change
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
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.
Detailed Description

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:

  1. Change in the 24-hour mean diastolic blood pressure from baseline to the day after post-treatment week-12 visit
  2. To evaluate the reduction in office blood pressure, including SeSBP and SeDPB, with Olmesartan 20mg therapy at 4,8,12 weeks (only for subjects with week-4, week-8 visit)
  3. Control rate [% of patients] at 12weeks, defined by Defined as SBP less than 140mmHg and / or DBP less than 90mmHg or a reduction more than 10 mmHg for DBP and / or more than 20mmHg SBP versus baseline values
  4. Biomarker assessment Vitamin D change from the baseline 24-hour urinary sodium excretion change from the baseline
  5. To evaluate the efficacy and tolerability of Olmesartan 20mg at 12 weeks based on global assessment by the physicians and patients

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:

  1. Test the improvement of blood pressure change in 24-hour blood pressure monitor by an angiotensin receptor blocker, Olmesartan, among hypertensive patients
  2. Test the change of vitamin D concentrations and 24-hour urinary sodium excretion change after this angiotensin receptor blocker, Olmesartan, treatment
  3. Test the association between blood pressure change and vitamin D-related measurements among the drug treatment, We hypothesize that the blood pressure change was related to the change of serum vitamin D concentration and also related to urinary sodium excretion change. .

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 200 patients with hypertension who received an angiotensin receptor antagonist, Olmesartan, for 12 weeks' treatment
Condition Hypertension
Intervention Drug: olmesartan
olmesartan
Study Groups/Cohorts Hypertension
Intervention: Drug: olmesartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 1, 2009)
100
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00854763
Other Study ID Numbers 20091036M
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Kuo-Liong Chien, MD, PhD Institute of Preventive Medicine, College of Public Health, National Taiwan University
PRS Account National Taiwan University Hospital
Verification Date February 2009