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]

UMIN ID: C000000324

Registered date:08/02/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2005/11/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

• Primary Outcome: Home blood pressure in the early morning assessed by the PROBE (prospective, randomized, open-endpoint, blinded) method
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Central Committee of FUJIYAMA Study
• Source(s) of Monetary Support: LINE-Nonprofit organization
• Secondary ID(s): NCT00288717,JapicCTI-060210