Hypertension, induced by the use of a Calcineurin Inhibitor (CNI)
Conditions
Interventions
Product Name: Amlodipine
Pharmaceutical Form: Tablet
INN or Proposed INN: AMLODIPINE
CAS Number: 88150-42-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Prod
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Treatment with tacrolimus • MDRD-GFR = 30 ml/min • Systolic blood pressure > 140 mmHg but =65 years) no F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • MDRD-GFR 1.0 g/10 mmol creatinine • Systolic blood pressure 180 mmHg during 24-hour blood pressure measurement • The use of co-trimoxazol or prednisone • Incapacitated subjects • Pregnancy • Use of a thiazide diuretic in combination with a calcium channel blocker • Use of loop diuretics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the blood pressure lowering effect of thiazides against calcium channel blockers in eczema or psoriasis patients with CNI-induced hypertension . ;Secondary Objective: Not applicable;Primary end point(s): Average 24-hour systolic blood pressure after eight weeks of treatment (twice).;Timepoint(s) of evaluation of this end point: At 8 and 18 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At 8 and 18weeks.;Secondary end point(s): • Incidence of hyperkalemia (serum potassium > 5.0 mmol/l) • Incidence of non-anion gap metabolic acidosis (serum bicarbonate < 20 mmol/l) • Incidence of edema (as assessed by physical examination) • Number of antihypertensive drugs • Side-effects: - Decrease in MDRD-GFR - Development of hyponatremia - Development of hypomagnesemia - Development of hypokalemia - Increase in HbA1c - Fluctuation in plasma tacrolimus level - Occurrence of gout | — |
Countries
Netherlands
Outcome results
None listed