Comparison of two drugs against high blood pressure in dermatology patients.
- Conditions
- Hypertension, induced by the use of a Calcineurin Inhibitor (CNI)Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2012-004704-35-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
• Treatment with tacrolimus
• MDRD-GFR = 30 ml/min
• Systolic blood pressure > 140 mmHg but < 180 mmHg during 24-hours blood pressure measurement
• Stable background antihypertensive drugs (i.e., no anticipated change in dose during the study period)
• 18 years or older
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5
• MDRD-GFR < 30 ml/min
• Serum sodium < 136 mmol/l
• Serum potassium < 3.5 mmol/l
• Proteinuria > 1.0 g/10 mmol creatinine
• Systolic blood pressure < 140 mmHg during 24-hour blood pressure measurement
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)<br>• Incidence of non-anion gap metabolic acidosis (serum bicarbonate < 20 mmol/l)<br>• Incidence of edema (as assessed by physical examination)<br>• Number of antihypertensive drugs<br>• Side-effects:<br> - Decrease in MDRD-GFR<br> - Development of hyponatremia<br> - Development of hypomagnesemia<br> - Development of hypokalemia <br> - Increase in HbA1c<br> - Fluctuation in plasma tacrolimus level<br> - Occurrence of gout