Essential HypertensionPhase 2NCT00709930
Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Fields in Mild and Moderate Essential Hypertension
A Phase 2 study testing Magnetic field generator in people with Essential Hypertension, run by Kyoto University at 1 site in Japan.
Trial summary
This study will evaluate the efficacy and safety of weak extremely low frequency electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Magnetic field generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2007to Dec 2008
- Phase
- Phase 2
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages: 20 years to 74 years
- Genders : Both
- The severity of hypertension: mild and moderate (WHO/ISH criteria stage I-II) Systolic blood pressure (SBP) >/= 140 and/or diastolic blood pressure (DBP)>/= 90 (untreated hypertension cases)
Who cannot join
- Any of the following medical conditions:
- Severe essential hypertension (DBP >110)
- Secondary or malignant hypertension
- History or symptoms of cerebral vascular disease
- History of myocardial infarction
- History of angina pectoris, atrial fibrillation, heart failure and arrhythmia
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- Renal dysfunction (serum creatinine > 2.1mg/dl)
- Severe hepatic dysfunction
- Uncontrolled diabetes
- Allergy, drug sensitivity or chronic skin disease
- Peptic ulcer disease
- Current pregnancy or lactation
- Depression that needs to be treated
- Hypertension controlled with antihypertensive medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo-Controlled Trial of Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Field in Mild and Moderate Essential Hypertension
This study will evaluate the efficacy and safety of weak extremely low frequency electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- Magnetic field generator, Placebo magnetic field generator
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic field generatorDevice
dosage:Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF frequency:10min/day duration:1 month
Placebo magnetic field generatorDevice
Placebo device with no magnetic fields
| Study group | Role | What they receive |
|---|---|---|
| 1,Exposed to ELF-EMF | Active comparator | Device: Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF Receives: Device: Magnetic field generator |
| 2,Placebo | Placebo comparator | Device: Placebo device with no magnetic fields Receives: Device: Placebo magnetic field generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the ELF-EMF and sham groups with respect to the absolute change in SBP value between baseline and the end of the exposure regimen (the age of the pre-exposure values for the last two sessions).
Measured: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
Secondary outcomes (3)
The difference between the ELF-EMF and sham groups with respect to the change in DBP value between baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
Measured: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
The change in both SBP and DBP values between pre-exposure and post-exposure for each session (averaged over the regimen)
Measured: for each session
The incidence of adverse events
Measured: during exposure and at the end of the exposure period and at six months after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2008
- Study completionDec 2008
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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Investigators
- Masanori Fukushima, Principal investigator, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709930
- Sponsor's protocol ID
- MF-II-01
- Status last verified
- Mar 2009
- First submitted
- 27 Jun 2008
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Trial of Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Field in Mild and Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT00709930
- Acronym / sponsor ID
- MF-II-01
- Conditions
- Essential Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Jul 2008 (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.
This study will evaluate the efficacy and safety of weak extremely low frequency electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1,Exposed to ELF-EMF | Active comparator | Device: Magnetic field generatorDevice: Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF |
| 2,Placebo | Placebo comparator | Device: Placebo magnetic field generatorDevice: Placebo device with no magnetic fields |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages: 20 years to 74 years
- Genders : Both
- The severity of hypertension: mild and moderate (WHO/ISH criteria stage I-II) Systolic blood pressure (SBP) >/= 140 and/or diastolic blood pressure (DBP)>/= 90 (untreated hypertension cases)
Key exclusion criteria (14 listed)
- Any of the following medical conditions:
- Severe essential hypertension (DBP >110)
- Secondary or malignant hypertension
- History or symptoms of cerebral vascular disease
- History of myocardial infarction
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 |
|---|---|---|
| Magnetic field generatordosage:Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF frequency:10min/day duration:1 month | Device | 1,Exposed to ELF-EMF |
| Placebo magnetic field generatorPlacebo device with no magnetic fields | Device | 2,Placebo |
Primary outcome
The difference between the ELF-EMF and sham groups with respect to the absolute change in SBP value between baseline and the end of the exposure regimen (the age of the pre-exposure values for the last two sessions).
Time frame: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
3 secondary outcomes
The difference between the ELF-EMF and sham groups with respect to the change in DBP value between baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
Time frame: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
The change in both SBP and DBP values between pre-exposure and post-exposure for each session (averaged over the regimen)
Time frame: for each session
The incidence of adverse events
Time frame: during exposure and at the end of the exposure period and at six months after exposure
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 31 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.
Masanori Fukushima principal investigator
Kyoto University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnetic field generator in people with Essential Hypertension, run by Kyoto 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 14 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 31 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 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The difference between the ELF-EMF and sham groups with respect to the absolute change in SBP value between baseline and the end of the exposure regimen (the age of the pre-exposure values for the last two sessions). (time frame: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)). 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 31 Mar 2009.