A Comparison of Indapamide SR 1.5 mg With Hydrochlorothiazide 25 mg, in Combination With an ACE-inhibitor, in Patients With Mild to Moderate Hypertension and Type 2 Diabetes Mellitus

Condition(s) targeted: Hypertension; Type 2 Diabetes Mellitus

Intervention: Hydrochlorothiazide (Drug); Indapamide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: LaborMed Pharma S.A.

Official(s) and/or principal investigator(s):
Dragos Vinereanu, Professor, MD, PhD, Principal Investigator, Affiliation: Cardiology, University and Emergency Hospital, Bucharest, Romania

Overall contact:
Dragos Vinereanu, MD, PhD, Phone: +40213180576, Email: dvinereanu@yahoo.com

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.

Official title: A Comparison of Indapamide SR 1.5 mg With Hydrochlorothiazide 25 mg, in Combination With an ACE-inhibitor, in Patients With Mild to Moderate Hypertension and Type 2 Diabetes Mellitus

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Better metabolic effects of indapamide SR 1.5 mg+quinapril by comparison with hydrochlorothiazide 25 mg+quinapril, in patients with hypertension and type 2 diabetes mellitus.

Secondary outcome:

Better antihypertensive effects of indapamide SR 1.5 mg+quinapril by comparison with hydrochlorothiazide 25 mg+quinapril, in patients with hypertension and type 2 diabetes mellitus.

Better effects on cardiac and arterial function of indapamide SR 1.5 mg+quinapril by comparison with hydrochlorothiazide 25 mg+quinapril, in patients with hypertension and type 2 diabetes mellitus

Better safety of indapamide SR 1.5 mg+quinapril by comparison with hydrochlorothiazide 25 mg+quinapril, in patients with hypertension and type 2 diabetes mellitus

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Dragos Vinereanu, MD, PhD, Phone: +40213180576, Email: dvinereanu@yahoo.com

Cardiology, University and Emergency Hospital, Bucharest 050098, Romania; Recruiting
Dragos Vinereanu, Professor, MD, PhD, Phone: +40213180576, Email: dvinereanu@yahoo.com
Andrea O Ciobanu, MD, Phone: +40213180576, Email: andreaciobanu7@yahoo.com
Andrea O Ciobanu, MD, Sub-Investigator
Stefania L Magda, MD, Sub-Investigator
Maria Florescu, MD, Sub-Investigator

Starting date: March 2008
Last updated: September 17, 2009