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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00980187 on ClinicalTrials.gov