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Recruitment status No longer recruiting
Unique ID issued by UMIN C000000324
Receipt No. 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

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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
Email

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
Email nakamo_h@saitama-med.ac.jp

Sponsor
Institute Central Committee of FUJIYAMA Study
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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