A PROSPECTIVE STUDY TO ASSESS THE INTERACTION BETWEEN PATIENT GENOTYPE AND ROSTAFUROXIN EFFECTS ON ARTERIAL BLOOD PRESSURE AND KIDNEY FUNCTION IN NEVER-TREATED HYPERTENSIVE TYPE 2 DIABETES PATIENTS (AN OPEN LABEL STUDY WITH BLINDED PATIENT GENOTYPE) - Rostafuroxin (PST2238) in Type 2 diabetes

• Conditions: Type 2 Diabetes.; MedDRA version: 14.1Level: LLTClassification code 10015491Term: Essential hypertension, unspecifiedSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1Level: LLTClassification code 10012612Term: Diabetes mellitus non insulin-depSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2011-000785-35-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Male and female patients; - Age > 18 years; - Hypertensive type 2 diabetes never-treated office systolic BP >135 mmHg in at least two consecutive visits one week apart (see Appendix 2); - High-normal, micro- or macro- albuminuria (urinary albumin excretion >10 mg/24 hours); - Normal kidney function (serum creatinine levels <1.4 mg/dl); - Capable of understanding the purpose of the study; - Written informed consent (signed and dated by the patient).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

- Concomitant treatment with drugs potentially affecting arterial BP, albuminuria or kidney function; - Secondary or grade 3 or more arterial hypertension (according to 2007 ESH/ESC Hypertension guidelines); - Non-diabetic renal disease, urinary tract infection, cardiovascular events over the last six months; - Any clinically relevant conditions that might affect study participation and/or study results; - Any contraindication to be exposed to Rostafuroxin; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified