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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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21 December 2021 |
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Main ID: |
EUCTR2006-001202-84-NL |
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Date of registration:
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31/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of the action of amiloride and thiazide in the reduction of lithium-NDI in patients with affective disorders - Treatment lithium-NDI
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Scientific title:
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Comparison of the action of amiloride and thiazide in the reduction of lithium-NDI in patients with affective disorders - Treatment lithium-NDI |
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Date of first enrolment:
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01/02/2007 |
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Target sample size:
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50 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001202-84 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Netherlands
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
-Patients treated with lithium for affective disorders
-Age above 18
-Having moderate to severe lithium NDI (maximal urinary concentration between 150 and 600 mOsm)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
-Hypo/hyperthyroidism
-Hypercalcaemia
-Hypokalemia/hyperkalemia
-Diabetes mellitus as a cause for the polyuria
-Renal insufficiency or underlying renal diseases
-Heart rhytm disorders
-Systolic blood pressure below 90 mmHg
-Treatment with hydrochlorothiazide or amiloride in the preceding 3 months, or treatment with other diuretics on the moment.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Lithium-induced Nephrogenic Diabetes Insipidus
MedDRA version: 9.1
Level: LLT
Classification code 10012600
Term: Diabetes insipidus nephrogenic
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Intervention(s)
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Trade Name: Midamor
Product Name: Amiloride
Pharmaceutical Form: Capsule*
Trade Name: Hydrochloorthiazide
Product Name: hydrochloorthiazide
Pharmaceutical Form: Capsule*
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Primary Outcome(s)
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Secondary Objective: To explore the effect of amiloride and thiazide on blood levels of sodium, potassium, chloride, bicarbonate, lithium, creatinine, hemoglobin and osmolality and urine levels of sodium, potassium, urea and creatinine, and osmolality and AQP2. Besides this, vital signs will be measured (bodyweight, blood pressure). Side effects, subjective symptoms and psychiatric outcome will also be recorded.
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Main Objective: To compare the effect of amiloride with the effect of hydrochlorothiazide on lithium-NDI, measured as urine volume and maximal urine osmolality
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Primary end point(s): -Maximal urine osmolality
-Urine volume (24 hrs)
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Secondary ID(s)
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lithium-15-12-06
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 29/01/2007
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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