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
NCT00980187 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2011-06-15
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.
Conditions
Interventions
- DRUG
-
Hydrochlorothiazide
orally, 25 mg, once a day, with Quinapril 10-40 mg, 6 months
- DRUG
-
Indapamide
1.5 mg SR, orally, once a day,with Quinapril 10-40 mg, 6 months
Sponsors & Collaborators
-
LaborMed Pharma S.A.
lead INDUSTRY
Principal Investigators
-
Dragos Vinereanu, Professor, MD, PhD · Cardiology, University and Emergency Hospital, Bucharest, Romania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2010-08-31
- Completion
- 2010-08-31
Countries
- Romania
Study Locations
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