A Randomized, Controlled Study on Calcium Channel Blocker versus Angiotensin II Antagonists in the Hypertensive Patients with Type 2 Diabetes Mellitus Under the Inadequately Controlled Blood Pressure with Angiotension II Antagonists

UMIN ID: C000000017

Registered date:29/06/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Hypertension with type 2 diabetes mellitus
• Date of first enrollment: 2004/11/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Maximum dosage of Angiotensin II receptor antagonists (candesartan cilexetil, losartan potassium, telmisartan, valsartan, olmesartan medoxomil) is administered from the beginning of the study (after randomized) over 3 years.
Normal dosage of AII antagonists + 5mg of Ca-channel blocker (amlodipine besilate) are administered from the beginning of the study (after randomized) over 3 years.

Outcome(s)

• Primary Outcome: -Changes in blood pressure level at home after gettin up. -The rate of the blood pressure levels at home after getting up, which effected the target levels(systolic blood pressure < 125mmHg, diastolic blood pressure < 80mmHg).
• Secondary Outcome: -Changes in blood pressure levels measured on an outpatient basis. -The rate of the blood pressure levels measured on an outpatient basis, which effected the standard levels(systolic blood pressure level < 130mmHg, diastolic blood pressure level < 80mmHg). -Changes in blood pressure levels measured at home before going to bed -Changes in IMT of the cervical artery -Changes in PWV -Changes in echocardiographic findings -Changes in urinary albumin level -Changes in BNP -Changes in hs-CRP -Medical cost-effectiveness -Adverse events, adverse drug reactions -Clinical laboratory data

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients with secondary hypertension. 2) Patients who show >180 mm Hg systolic or >110 mm Hg diastolic of the ambulatory blood pressure levels measured (in the sitting position) at the time of start of the observation period. 3) Patients with severe hepatic dysfunction. 4) Patients with severe renal dysfunction. 5) Patients with a past history of hypersensitiveness to study drugs. 6) Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period. 7) Patients who have attended the trial within 3 months before the start of the observation periond or who attend the trial simultaneously with the present study. 8) Other patients judged as being inappropriate for the subjects of the study by investigators.

Related Information

• Primary Sponsor: Central Coordinating Committee of ADVANCED-J Study Group
• Source(s) of Monetary Support: Japan Heart Foundation (JHF)
• Secondary ID(s): NCT00144144