A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFECT OF 6-MONTH ACETYLCARNITINE THERAPY ON ARTERIAL BLOOD PRESSURE, LIPID AND METABOLIC PROFILE, AND KIDNEY FUNCTION IN HYPERTENSIVE PATIENTS WITH TYPE 2 DIABETES ON BACKGROUND SIMVASTATIN THERAPY (DIABASI STUDY) - Acetylcarnitine in type 2 diabetes

Phase 1

Active, not recruiting

• Conditions: Diabetes; MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

• Registration Number: EUCTR2007-005925-31-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-31
• Study Completion: 2012-03-26
• Last Update Posted: 2019-06-30

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 228

Inclusion Criteria

- Males and females >40 years old; - High-risk subjects with type 2 diabetes (WHO criteria); - High blood pressure (systolic blood pressure >140 mmHg or with concomitant antihypertensive treatment stable since at least 3 months); - Serum creatinine concentration <1.5 mg/dl;- Patients legally able to give written informed consent to the trial (signed and dated by the patient); - Written informed consent.
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

- Uncontrolled diabetes (glycated hemoglobin >11%); - Acute cardiovascular events over the last 3 months; - Specific contraindications or history of hypersensitivity to the study drugs; - Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer; - Drug or alcohol abuse; - Any chronic clinical conditions that may affect completion of the trial or confound data interpretation; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial; - Evidence of an uncooperative attitude; - Any evidence that patient will not be able to complete the trial follow-up.

Study & Design

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