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 - Full Text View

Sponsor:	LaborMed Pharma S.A.
Information provided by:	LaborMed Pharma S.A.
ClinicalTrials.gov Identifier:	NCT00980187

Purpose

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.

Condition	Intervention	Phase
Hypertension Type 2 Diabetes Mellitus	Drug: Hydrochlorothiazide Drug: Indapamide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Hydrochlorothiazide Indapamide

U.S. FDA Resources

Further study details as provided by LaborMed Pharma S.A.:

Primary Outcome Measures:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Hydrochlorothiazide: Active Comparator	Drug: Hydrochlorothiazide orally, 25 mg, once a day, with Quinapril 10-40 mg, 6 months
Indapamide SR: Experimental	Drug: Indapamide 1.5 mg SR, orally, once a day,with Quinapril 10-40 mg, 6 months

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980187

Contacts

Contact: Dragos Vinereanu, MD, PhD	+40213180576	dvinereanu@yahoo.com
Contact: Andrea O Ciobanu, MD	+40213180576	andreaciobanu7@yahoo.com

Locations

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

Sponsors and Collaborators

LaborMed Pharma S.A.

Investigators

Principal Investigator:

Dragos Vinereanu, Professor, MD, PhD

Cardiology, University and Emergency Hospital, Bucharest, Romania

More Information

No publications provided

Responsible Party:	University and Emergency Hospital Bucharest, Cardiology Department ( Professor Dragos Vinereanu )
Study ID Numbers:	RO-SCL-IQ v 1.0/04.07
Study First Received:	September 17, 2009
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00980187 History of Changes
Health Authority:	Romania: National Medicines Agency

Keywords provided by LaborMed Pharma S.A.:

blood tests
cardiac function
endothelial function
arterial function

Additional relevant MeSH terms:

Indapamide
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Sodium Chloride Symporter Inhibitors
Physiological Effects of Drugs
Diuretics
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010