Essential HypertensionPhase 4ONEASTNCT00509470
Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine
A Phase 4 study testing telmisartan plus hydrochlorothiazide and Amlodipine in people with Essential Hypertension, run by Tokyo University at 1 site in Japan.
Trial summary
The purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- telmisartan plus hydrochlorothiazide and Amlodipine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2007to Oct 2012
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 5 mg/day of amlodipine is administered for more than 3 months
- Systolic or diastolic blood pressure >= 140/90 mmHg (more than 2 times measurements at outpatient clinic before start of the study)
- Outpatients
Who cannot join
- Secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis
- Administration of antihypertensives other than amlodipine
- Cardiovascular disease (cerebral hemorrhage, cerebral infarction, TIA, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study
- Serum creatinine >= 2.0 mg/dl
- Severe hypertension (systolic or diastolic blood pressure >= 180/110 mmHg) or malignant hypertension (hypertensive organ damage is rapidly developing)
- Chronic heart failure (NYHA class>=III to VI)
Show all 11Show fewer
- Contraindication of telmisartan or hydrochlorothiazide
- Hyper- (>= 5.5 mEq/L) or hypo- (<=3.5 mEq/l) potassemia
- Untreated hyperuricemia or uncontrolled hyperuricemia (serum uric acid >= 8.0 mg/dl)
- Diabetic patients who require insulin therapy, uncontrolled diabetic patients (hemoglobin A1c >=9.0%), or patients who possess the risk of hypoglycemic attack
- Patients inadequate for the study
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
Tokyo, 113-8655
About this study
Official title: ONgoing Evaluation of Depressor Effect And Safety of Combination Therapy With Telmisartan and Low-dose Hydrochlorothiazide in Patients With Hypertension Uncontrolled on Amlodipine Treatment
The purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients.
Read the detailed description
In hypertensive patients whose blood pressure (BP) does not reach less than 140/90 mmHg with 5mg/day of amlodipine are divided the following two groups and BP response, laboratory data, and adverse effects are compared. Group 1: 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide. Group 2: Amlodipine is continuously administered.
- Conditions
- Essential Hypertension
- Being tested
- telmisartan plus hydrochlorothiazide, Amlodipine
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartan plus hydrochlorothiazideDrug
Combination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day
AmlodipineDevice
| Study group | Role | What they receive |
|---|---|---|
| telmisartan plus low-dose hydrochlorothiazide | Active comparator | 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide Receives: Drug: telmisartan plus hydrochlorothiazide |
| Amlodipine | Active comparator | Amlodipine is continuously administered. Receives: Device: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in office blood pressure
Measured: After 12 week treatment
Secondary outcomes (1)
1) Home blood pressure in early morning and before going to bed 2) Changes in uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting plasma glucose (only in diabetic patients), hemoglobin A1c (only in diabetic patients
Measured: After 12 week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroshi Satonaka, Tokyo University
- Investigators
- Toshiro Fujita, MD, PhD, Principal investigator, Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509470
- Sponsor's protocol ID
- P2007008
- Acronym
- ONEAST
- Status last verified
- Oct 2016
- First submitted
- 28 Jul 2007
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONgoing Evaluation of Depressor Effect And Safety of Combination Therapy With Telmisartan and Low-dose Hydrochlorothiazide in Patients With Hypertension Uncontrolled on Amlodipine Treatment
- ClinicalTrials.gov ID
- NCT00509470
- Acronym / sponsor ID
- ONEAST / P2007008
- Conditions
- Essential Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 Jul 2007 (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.
The purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients.
Detailed description
In hypertensive patients whose blood pressure (BP) does not reach less than 140/90 mmHg with 5mg/day of amlodipine are divided the following two groups and BP response, laboratory data, and adverse effects are compared. Group 1: 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide. Group 2: Amlodipine is continuously administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telmisartan plus low-dose hydrochlorothiazide | Active comparator | Drug: telmisartan plus hydrochlorothiazide12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide |
| Amlodipine | Active comparator | Device: AmlodipineAmlodipine is continuously administered. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 5 mg/day of amlodipine is administered for more than 3 months
- Systolic or diastolic blood pressure >= 140/90 mmHg (more than 2 times measurements at outpatient clinic before start of the study)
- Outpatients
Key exclusion criteria (11 listed)
- Secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis
- Administration of antihypertensives other than amlodipine
- Cardiovascular disease (cerebral hemorrhage, cerebral infarction, TIA, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study
- Serum creatinine >= 2.0 mg/dl
- Severe hypertension (systolic or diastolic blood pressure >= 180/110 mmHg) or malignant hypertension (hypertensive organ damage is rapidly developing)
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 |
|---|---|---|
| telmisartan plus hydrochlorothiazideCombination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day | Drug | telmisartan plus low-dose hydrochlorothiazide |
| Amlodipine | Device | Amlodipine |
Primary outcome
Changes in office blood pressure
Time frame: After 12 week treatment
1 secondary outcome
1) Home blood pressure in early morning and before going to bed 2) Changes in uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting plasma glucose (only in diabetic patients), hemoglobin A1c (only in diabetic patients
Time frame: After 12 week treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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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.
Toshiro Fujita, MD, PhD principal investigator
Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing telmisartan plus hydrochlorothiazide and Amlodipine in people with Essential Hypertension, run by Tokyo University at 1 site in Japan.
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 11 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: finished, as of the sponsor's last update on 18 Oct 2016. 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 Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in office blood pressure (time frame: After 12 week treatment). 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 18 Oct 2016.