HypertensionNCT00288717
Effectiveness of Candesartan and Telmisartan on Morning Hypertension in Japanese Obese Patients
A study testing Candesartan and Telmisartan in people with Hypertension, run by Saitama Medical University at 1 site in Japan.
Trial summary
To investigate the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by the newly developed Tele-medicine system Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Candesartan and Telmisartan
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2006to Sep 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Circumference at waist: male ≧85 cm, female ≧90 cm
- Hypertensive patient with untreated hypertension, and casual blood pressure of systole ≧140 mmHg, or diastole ≧90 mmHg
- Hypertensive patient with hypertension under treatment, and casual blood pressure of systole ≧130 mmHg, or diastole ≧85 mmHg
Who cannot join
- Significant hypertensive patient with diastolic blood pressure ≧120 mmHg
- Malignant hypertensive patient
- Patient with a contraindication to the study drugs (hypersensitivity, significant hepatic diseases, pregnant woman)
- Patient with urinary protein (qualitative) ＋～＋＋
- Patient with familial hyperlipidemia
- Other patients judged as ineligible for the study
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Saitama Medical School Department of Renal Medicine
Saitama, Saitama, 350-0495
Hidetomo Nakamoto, MD, +81-492-76-1258, nakamo_h@saitama-med.ac.jp
Hidetomo Nakamoto, MD
About this study
Official title: A Randomized, Comparative Study of the Effects of Candesartan and Telmisartan on the Home Blood Pressure, Glucose and Lipid Metabolism in the Hypertensive Patients With the Accumulation of Visceral Fat by the Central Registration System
To investigate the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by the newly developed Tele-medicine system
Read the detailed description
A randomized, comparative study of the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid metabolism in the hypertensive patients with the accumulation of visceral fat by the central registration system
- Conditions
- Hypertension
- Being tested
- Candesartan, Telmisartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
TelmisartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Home blood pressure in the early morning
Secondary outcomes (18)
Home blood pressure at bedtime
M/E ratio
Casual blood pressure
Body fat percentage
Body weight
Height
BMI
Blood potassium
Total cholesterol
HDL cholesterol
LDL cholesterol
Triglyceride
Blood glucose
IRI
HbAlc*
HOMA-IR
Urinary trace albumin
Creatinine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionSep 2007
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Saitama Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Non-Profit Organaizaion "LINE"
- Investigators
- Hidetomo Nakamoto, MD, Principal investigator, Saitama Medical School Department of Renal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288717
- Sponsor's protocol ID
- FUJIYAMA-Study
- Other IDs
- UMIN-CTR-C000000324
- Status last verified
- Jan 2007
- First submitted
- 7 Feb 2006
- Last updated
- 11 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparative Study of the Effects of Candesartan and Telmisartan on the Home Blood Pressure, Glucose and Lipid Metabolism in the Hypertensive Patients With the Accumulation of Visceral Fat by the Central Registration System
- ClinicalTrials.gov ID
- NCT00288717
- Acronym / sponsor ID
- FUJIYAMA-Study
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Saitama Medical UniversityUniversity, hospital or other
- Collaborators
- Non-Profit Organaizaion "LINE"
- Study start
- Feb 2006
- Study completion
- Sep 2007
- First posted
- 8 Feb 2006 (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.
To investigate the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by the newly developed Tele-medicine system
Detailed description
A randomized, comparative study of the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid metabolism in the hypertensive patients with the accumulation of visceral fat by the central registration system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Circumference at waist: male ≧85 cm, female ≧90 cm
- Hypertensive patient with untreated hypertension, and casual blood pressure of systole ≧140 mmHg, or diastole ≧90 mmHg
- Hypertensive patient with hypertension under treatment, and casual blood pressure of systole ≧130 mmHg, or diastole ≧85 mmHg
Key exclusion criteria (6 listed)
- Significant hypertensive patient with diastolic blood pressure ≧120 mmHg
- Malignant hypertensive patient
- Patient with a contraindication to the study drugs (hypersensitivity, significant hepatic diseases, pregnant woman)
- Patient with urinary protein (qualitative) ＋～＋＋
- Patient with familial hyperlipidemia
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 |
|---|---|---|
| Candesartan | Drug | – |
| Telmisartan | Drug | – |
Primary outcome
Home blood pressure in the early morning
18 secondary outcomes
Home blood pressure at bedtime
M/E ratio
Casual blood pressure
Body fat percentage
Body weight
Height
BMI
Blood potassium
Total cholesterol
HDL cholesterol
LDL cholesterol
Triglyceride
Blood glucose
IRI
HbAlc*
HOMA-IR
Urinary trace albumin
Creatinine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2007.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Hidetomo Nakamoto, MD principal investigator
Saitama Medical School Department of Renal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Candesartan and Telmisartan in people with Hypertension, run by Saitama Medical 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 6 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 11 Jan 2007. 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.
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 Hidetomo Nakamoto, MD (+81-0492-76-1258, nakamo_h@saitama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home blood pressure in the early morning. 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 11 Jan 2007.