UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000324 |
|---|---|
| Receipt number | R000000416 |
| Scientific Title | A randomized, comparative study of the effectiveness of sartans on the morning hypertension and metabolic abnormality in the Japanese obese patients by the central registration system.[FUJIYAMA-Study] |
| Date of disclosure of the study information | 2006/02/08 |
| Last modified on | 2008/02/13 12:29:22 |
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Basic information
Public title
A randomized, comparative study of the effectiveness of sartans on the morning hypertension and metabolic abnormality in the Japanese obese patients by the central registration system.[FUJIYAMA-Study]
Acronym
A randomized, comparative study of the effectiveness of sartans on the morning hypertension and metabolic abnormality in the Japanese obese patients by the central registration system.[FUJIYAMA-Study]
Scientific Title
A randomized, comparative study of the effectiveness of sartans on the morning hypertension and metabolic abnormality in the Japanese obese patients by the central registration system.[FUJIYAMA-Study]
Scientific Title:Acronym
A randomized, comparative study of the effectiveness of sartans on the morning hypertension and metabolic abnormality in the Japanese obese patients by the central registration system.[FUJIYAMA-Study]
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Home blood pressure in the early morning assessed by the PROBE (prospective, randomized, open-endpoint, blinded) method
Key secondary outcomes
Home blood pressure at bedtime
M/E ratio**
Casual blood pressure
Obesity: body fat percentage, weight, height, BMI**
Blood potassium*
Serum lipid: total cholesterol*, HDL cholesterol*, LDL cholesterol*
Triglyceride*
Glucose metabolism: blood glucose*, IRI* , HbAlc*, HOMA-IR**
Renal function: urinary microalbumin*, creatinine*
Adverse effects
assessed by the PROBE method
* : measured together by the clinical laboratory
assessed by the PROBE method
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Candesartan group(C-group):
1.Method of administration
1)Observation period: Continue the treatment of the pre-study regimen, and observe over 2 weeks. However, set a washout period of 4 weeks when any angiotensin II receptor antagonist is given.
2)Treatment period:
For the C-group:- In principle, continue Candesartan 8 mg once daily in the morning for 12 weeks.However, the administration may be initiated with Candesartan 4 mg if necessary.
Set the target levels of casual blood pressures as the systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg.
When antihypertensive effect is inadequate, the dose may be increased to Candesartan 12 mg or Telmisartan 80 mg, however, the dosage should not be
changed at 8 weeks or later.
2.Concomitant drugs:
Concomitant uses of the angiotensin II receptor antagonists other than study drugs, fibrates and ethyl eicosapentoate (EPA) are prohibited.
The dosage of other antihypertensive drugs should be maintained as much as possible during the study period, however, increase or addition in dosage may be allowed when the antihypertensive effect is inadequate after the increase of the dosage.
Interventions/Control_2
Telmisartan group(T-group):
1.Method of administration
1)Observation period: Continue the treatment of the pre-study regimen, and observe over 2 weeks. However, set a washout period of 4 weeks when any angiotensin II receptor antagonist is given.
2)Treatment period:
For the T-group:- In principle, continue Telmisartan 40 mg once daily in the morning for 12 weeks. However, the administration may be initiated with Telmisartan 20 mg if necessary.
Set the target levels of casual blood pressures as the systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg.
When antihypertensive effect is inadequate, the dose may be increased to Candesartan 12 mg or Telmisartan 80 mg, however, the dosage should not be
changed at 8 weeks or later.
2.Concomitant drugs:
Concomitant uses of the angiotensin II receptor antagonists other than study drugs, fibrates and ethyl eicosapentoate (EPA) are prohibited.
The dosage of other antihypertensive drugs should be maintained as much as possible during the study period, however, increase or addition in dosage may be allowed when the antihypertensive effect is inadequate after the increase of the dosage.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patient with circumference at waist:male >=85 cm, female >=90 cm
2)Hypertensive patient falls under the following conditions:
i)with untreated hypertension, and casual blood pressure of systole >=40 mmHG, or diastole >=90 mmHg
ii)with hypertension under treatment, and casual blood pressure of systole >=130 mmHg, or diastole >=85 mmHg
Key exclusion criteria
1)Significant hypertensive patient with diastolic blood pressure >=120 mmHg
2)Malignant hypertensive patient
3)Patient with a contraindication to the study drugs (hypersensitivity, significant hepatic diseases, pregnant woman)
4)Patient with urinary protein (qualitative) + to ++
5)Patient with familial hyperlipidemia (hypercholesterolemia, hypertriglyceridemia)
6)Other patients judged as ineligible for the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical School
Division name
Department of Renal Medicine
Zip code
Address
38, Moro-Hongo, Moroyama, Iruma-gun, Saitama 350-0495, Japan
TEL
0492-76-1258
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical School
Division name
Department of Renal Medicine
Zip code
Address
38, Moro-Hongo, Moroyama, Iruma-gun, Saitama 350-0495, Japan
TEL
0492-76-1258
Homepage URL
nakamo_h@saitama-med.ac.jp
Sponsor or person
Institute
Central Committee of FUJIYAMA Study
Institute
Department
Personal name
Funding Source
Organization
LINE-Nonprofit organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00288717
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
JapicCTI-060210
Org. issuing International ID_2
Japan Pharmaceutical Information Center
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2005 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 02 | Month | 06 | Day |
Last modified on
| 2008 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000416
