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 | Completed Phase 4

• 1 other identifier: RO-SCL-IQ v 1.0/04.07
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension; Type 2 Diabetes Mellitus

Keywords

blood tests; cardiac function; endothelial function; arterial function

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• 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.

  6 months

• 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

  6 months

• 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

  6 months

Study Arms (2)

Hydrochlorothiazide

ACTIVE COMPARATOR

Drug: Hydrochlorothiazide

Indapamide SR

EXPERIMENTAL

Drug: Indapamide

Interventions

Hydrochlorothiazide DRUG

orally, 25 mg, once a day, with Quinapril 10-40 mg, 6 months

Also known as: Nefrix

Hydrochlorothiazide

Indapamide DRUG

1.5 mg SR, orally, once a day,with Quinapril 10-40 mg, 6 months

Also known as: Indapamid LPH

Indapamide SR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LaborMed Pharma S.A.: lead

Study Sites (1)

Cardiology, University and Emergency Hospital

Bucharest, 050098, Romania

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

Hydrochlorothiazide; Indapamide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amides; Indoles

Study Officials

• Dragos Vinereanu, Professor, MD, PhD

  Cardiology, University and Emergency Hospital, Bucharest, Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: March 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 15, 2011

Record last verified: 2011-06

Locations

RO (1)