EUCTR2015-001501-14-FR
Active, not recruiting
Phase 1
Pilot study of aprepitant effect on aldosterone secretion in diabetic patient (diabetes mellitus) with hypertension associated with low renin - APHOS-02
Rouen University Hospital0 sites20 target enrollmentJanuary 29, 2016
ConditionsDiabetic patient (diabetes mellitus) with hypertension associated with low reninMedDRA version: 18.1Level: HLTClassification code 10052741Term: Endocrine and metabolic secondary hypertensionSystem Organ Class: 100000004866MedDRA version: 18.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsEMEND
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetic patient (diabetes mellitus) with hypertension associated with low renin
- Sponsor
- Rouen University Hospital
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or menopausal female subjects;
- •Age ranging 18\-30 years old;
- •Submitted to a social security regimen;
- •Agreeing to the study \& Informed consent form signed;
- •Body mass index (\[weight (kg)/height (m)]²) \< 27;
- •No treatment received 6 weeks before inclusion;
- •No anomaly after: complete clinical examination, pulse and blood pressure measurement, ECG;
- •No biological abnormality after the following biological testing:
- •Hematology: white \& red blood cells \& platelets count, haemoglobin, hematocrit,
- •Blood biochemistry: sodium, potassium, chloride, bicarbonate, creatinine, urea,
Exclusion Criteria
- •Female subject potentially pregnant,
- •Subject younger than 18 year\-old and older than 70 year\-old,
- •Subject without diabetes condition or with diabetes but normal blood pressure (below 130/80 mmHg),
- •Subject with glycated hemoglobin HbA1c \< 6\.5% or \>11%,
- •Subject with leuconeutropenia (neutrophils below 1700/mm3\),
- •Subject with severe medical or surgical history,
- •Patients treated with drugs metabolized by CYP3A4 and CYP2C9: corticosteroids, vitamin K , hormonal contraceptives, tolbutamide, benzodiazepines, derived from ergot, antiepileptics, hypericum, macrolides, azole antifungals.
- •Patients treated with drugs interfering with the renin\-angiotensin\- aldosterone system : beta\-blockers, diuretics , anti \-aldosterone drugs , direct renin inhibitors , insulin,
- •type 2 diabetes patients with a vegetative autonomic neuropathy,
- •Patients with adrenal mass was diagnosed at imaging,
Outcomes
Primary Outcomes
Not specified
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