A Phase 4 interventional study of Candesartan and Candesartan and Cilnidipine in Kidney, Polycystic, Autosomal Dominant, sponsored by Kyorin University. Status unknown at 6 sites in Japan. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2007-10-18.
Sponsored by Kyorin University · Phase 4, Interventional, and Treatment
This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.
158 studies on the registry are indexed under Polycystic Kidney Diseases; 21 are open to participants now.
This study's planned enrollment of 150 is above the median of 46 across 115 interventional studies indexed under Polycystic Kidney Diseases.
Browse Polycystic Kidney Diseases studies →Kyorin University is the lead sponsor of 33 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
ADPKD patients with blood pressure above 130/85 are enrolled. The patients whose blood pressure is controlled under 130/85 by Candesartan alone are classified into group A.
Drug: Candesartan
The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group B, blood pressure is controlled by Candesartan plus Cilnidipine. If blood pressure is not lowered by Candesartan plus Cilnidipine alone, another antihypertensive agents except CCB and ACEI are allowable.
Drug: Candesartan and Cilnidipine
The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group C, blood pressure is controlled by Candesartan plus non-CCB agents such as beta- or alpha- adrenergic blockers or another ARB. Any CCB and ACEI are not allowable.
Drug: Candesartan plus non-CCB agents
Candesartan upto 8mg
Candesartan upto 8mg per day and Cilnidipine upto 20mg per day
Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI
Kidney Volume measured by MRI.
Time frame: Every year
Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events
Time frame: any time during study period
This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Kyorin University