HypertensionNCT00854763
Olmesartan on Ambulatory Blood Pressure Change
An observational study of Hypertension, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- olmesartan
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 patients with hypertension who received an angiotensin receptor antagonist, Olmesartan, for 12 weeks' treatment
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Kuo-Liong Chien, MD, PhD, +886-2-3366-8017, klchien@ntu.edu.tw
Kuo-Liong Chien, MD, PhD
About this study
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
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.
Read the 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:
- Change in the 24-hour mean diastolic blood pressure from baseline to the day after post-treatment week-12 visit
- 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)
- 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
- Biomarker assessment Vitamin D change from the baseline 24-hour urinary sodium excretion change from the baseline
- 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:
- Test the improvement of blood pressure change in 24-hour blood pressure monitor by an angiotensin receptor blocker, Olmesartan, among hypertensive patients
- Test the change of vitamin D concentrations and 24-hour urinary sodium excretion change after this angiotensin receptor blocker, Olmesartan, treatment
- 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.
- Conditions
- Hypertension
- Being tested
- olmesartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olmesartanDrug
olmesartan
| Study group | Role | What they receive |
|---|---|---|
| Hypertension | Not described Receives: Drug: olmesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kuo-Liong Chien, MD, PhD, Principal investigator, Institute of Preventive Medicine, College of Public Health, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854763
- Sponsor's protocol ID
- 20091036M
- Status last verified
- Feb 2009
- First submitted
- 1 Mar 2009
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00854763
- Acronym / sponsor ID
- 20091036M
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Change in the 24-hour mean diastolic blood pressure from baseline to the day after post-treatment week-12 visit
- 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)
- 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
- Biomarker assessment Vitamin D change from the baseline 24-hour urinary sodium excretion change from the baseline
- 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:
- Test the improvement of blood pressure change in 24-hour blood pressure monitor by an angiotensin receptor blocker, Olmesartan, among hypertensive patients
- Test the change of vitamin D concentrations and 24-hour urinary sodium excretion change after this angiotensin receptor blocker, Olmesartan, treatment
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertension | – | Drug: olmesartan |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients with hypertension who received an angiotensin receptor antagonist, Olmesartan, for 12 weeks' treatment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olmesartanolmesartan | Drug | Hypertension |
Primary outcome
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
1 secondary outcome
Change in the 24-hour mean diastolic blood pressure from baseline to the day after post-treatment week-12 visit
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuo-Liong Chien, MD, PhD principal investigator
Institute of Preventive Medicine, College of Public Health, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuo-Liong Chien, MD, PhD (+886-2-3366-8017, klchien@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2009.