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Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

Primary Purpose

Hypertension, Renal Insufficiency

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Indapamide
Hydrochlorothiazide
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, renal insufficiency, indapamide, hydrochlorothiazide

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Creatinine clearance 30 to 90 mL/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation.
  • Diagnosed hypertension according to guidelines or having taken anti-hypertension drugs.
  • Aged between 65 and 85 years.
  • Willingness to provide written, informed consent.
  • Ability to adhere to study protocol.

Exclusion Criteria:

  • Secondary hypertension.
  • Diabetes mellitus.
  • Atrial flutter/atrial fibrillation.
  • Symptoms of congestive heart failure (NYHA III-IV) or there is evidence that left ventricular EF < 40%.
  • Recent (< 6 months) myocardial infarction or cerebrovascular ischemic symptoms.
  • Recent (< 3 months) or planned coronary revascularization: PCI (percutaneous coronary intervention)/CABG (coronary artery by-pass graft).
  • Severe valvular heart disease.
  • History of hypersensitivity to indapamide, thiazides or to any of the components of the products.
  • Any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs.
  • Participation to another investigational study in the last 3 months.

Sites / Locations

  • Department of Cardiology, West China Hospital, Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indapamide

Hydrochlorothiazide

Arm Description

Indapamide SR 1.5mg qd

Hydrochlorothiazide 25mg qd

Outcomes

Primary Outcome Measures

renal function
Effects of indapamide SR 1.5 mg on renal function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.

Secondary Outcome Measures

endothelial function
Effects of indapamide SR 1.5 mg on endothelial function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
blood pressure variability
Effects of indapamide SR 1.5 mg on blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension

Full Information

First Posted
July 26, 2010
Last Updated
June 23, 2014
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01172431
Brief Title
Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency
Official Title
A Comparison of Indapamide SR 1.5 mg With Hydrochlorothiazide 25 mg, in Combination With an ACE-inhibitor, in Old Patients With Mild to Moderate Renal Insufficiency and Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal function, endothelial function, blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Renal Insufficiency
Keywords
hypertension, renal insufficiency, indapamide, hydrochlorothiazide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indapamide
Arm Type
Experimental
Arm Description
Indapamide SR 1.5mg qd
Arm Title
Hydrochlorothiazide
Arm Type
Active Comparator
Arm Description
Hydrochlorothiazide 25mg qd
Intervention Type
Drug
Intervention Name(s)
Indapamide
Intervention Description
Indapamide SR 1.5mg qd
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Intervention Description
Hydrochlorothiazide 25mg qd
Primary Outcome Measure Information:
Title
renal function
Description
Effects of indapamide SR 1.5 mg on renal function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
endothelial function
Description
Effects of indapamide SR 1.5 mg on endothelial function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
Time Frame
1 year
Title
blood pressure variability
Description
Effects of indapamide SR 1.5 mg on blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Creatinine clearance 30 to 90 mL/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation. Diagnosed hypertension according to guidelines or having taken anti-hypertension drugs. Aged between 65 and 85 years. Willingness to provide written, informed consent. Ability to adhere to study protocol. Exclusion Criteria: Secondary hypertension. Diabetes mellitus. Atrial flutter/atrial fibrillation. Symptoms of congestive heart failure (NYHA III-IV) or there is evidence that left ventricular EF < 40%. Recent (< 6 months) myocardial infarction or cerebrovascular ischemic symptoms. Recent (< 3 months) or planned coronary revascularization: PCI (percutaneous coronary intervention)/CABG (coronary artery by-pass graft). Severe valvular heart disease. History of hypersensitivity to indapamide, thiazides or to any of the components of the products. Any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs. Participation to another investigational study in the last 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao P Chen, master
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

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Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

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