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Clinical Trials/EUCTR2007-005925-31-IT
EUCTR2007-005925-31-IT
Active, not recruiting
Phase 1

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

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 sites228 target enrollmentMarch 31, 2009
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DrugsZIBREN

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Enrollment
228
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 31, 2009
End Date
March 26, 2012
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
IST. DI RICERCHE FARMACOLOG. M. NEGRI

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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