A Comparison of Indapamide SR 1.5 mg With HCTZ 25 mg, in Combination With an ACE-inhibitor, in Patients With Mild to Moderate AHT and Type 2 DM

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the effects of indapamide SR 1.5 mg on blood pressure, blood tests (glucose metabolism, lipids, minerals, and uric acid), cardiac function, endothelial and arterial function, by comparison with hydrochlorothiazide 25 mg, in patients with hypertension and type 2 diabetes mellitus. In order to achieve a better control of blood pressure in these patients, each diuretic treatments will be added to an ACE inhibitor (quinapril 10-40 mg/day). Therefore, eventually, the study will provide data on the comparison between combination indapamide SR 1.5 mg + quinapril versus hydrochlorothiazide 25 mg + quinapril.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LaborMed Pharma S.A.
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Hydrochlorothiazide; Indapamide

Criteria

Inclusion Criteria:

Only diabetic patients presenting all of the following criteria should be enrolled into the study:

• Aged between 18 and 75 years .

• Daytime ambulatory blood pressure >135 and/or >85 mm Hg (only mild to moderate hypertension can be included in the study), and type 2 diabetes mellitus. The blood pressure monitoring device will be installed at visit 0 (Screening) and the conclusion of this monitoring will be evaluated at Visit1, before randomization.

• Sinus rhythm.

• Ability to understand the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the Investigator/Co-investigator, and to comply with the requirements of the study. Any anti-hypertensive medication will be stopped at least two weeks prior to randomisation.

• Informed written consent given before the initiation of the pre-study screening.

Exclusion Criteria:

• Secondary hypertension

• Severe hypertension ( ≥ 180 and/or ≥110 mm Hg); stage III hypertension (WHO classification)

• Symptoms of congestive heart failure (NYHA II - IV) or left ventricular global systolic dysfunction (EF < 40%)

• Ventricular aneurysm or extensive wall motion abnormalities

• Recent (< 6 months) myocardial infarction

• Recent (< 3 months) or planned coronary revascularization: PCI (percutaneous coronary intervention)/CABG (coronary artery by-pass graft)

• Severe valvular heart disease/congenital heart disease

• Hypertrophic cardiomyopathy

• Pericarditis

• Chronic cor pulmonale

• Recent (< 6 months) cerebrovascular ischemic symptoms (e.g. transient ischemic accident, prolonged reversible ischemic neurological deficit, stroke)

• Creatinine level >1.5 mg/dl for men or >1.4 mg/dl for women

• Pregnancy or patients who plan to become pregnant during the study period (only for female subjects).

• Breast-feeding woman

• Presence or history of relevant medical conditions, including: cancer, HIV, significant disease of the renal, hepatic, gastrointestinal, respiratory, endocrine, locomotor systems, or significant metabolic, haematological, neurological disorders

• History of hypersensitivity to indapamide, quinapril, thiazides or to any of the components of the products; contraindication to any of the study medications

• Significant acute illness within 14 days prior to randomisation

• Any history of drug or alcohol abuse, recent psychiatric disorder or use of psychotropic substances

• Any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs

• Current use of hormonal contraceptive drugs (only for female subjects); non-hormonal contraceptive measures have to be used, for female patients of childbearing potential, as follows: diaphragm, male condom, intrauterine device, tube ligation, selective tube occlusion procedure, or vasectomy of the partner

• Participation to another investigational study in the last 3 months