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Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiaoping Chen, West China Hospital
ClinicalTrials.gov Identifier:
NCT01172431
First received: July 26, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Renal Insufficiency
Drug: Indapamide
Drug: Hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by West China Hospital:

Primary Outcome Measures:
  • renal function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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


Enrollment: 240
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indapamide
Indapamide SR 1.5mg qd
Drug: Indapamide
Indapamide SR 1.5mg qd
Other Name: Indapamide
Active Comparator: Hydrochlorothiazide
Hydrochlorothiazide 25mg qd
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg qd
Other Name: Hydrochlorothiazide

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172431

Locations
China, Sichuan
Department of Cardiology, West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
Principal Investigator: Xiao P Chen, master West China Hospital
  More Information

No publications provided

Responsible Party: Xiaoping Chen, Xiaoping Chen, professor, West China Hospital of Sichuan University., West China Hospital
ClinicalTrials.gov Identifier: NCT01172431     History of Changes
Other Study ID Numbers: WestChinaH
Study First Received: July 26, 2010
Last Updated: June 23, 2014
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by West China Hospital:
hypertension
renal insufficiency
indapamide
hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Renal Insufficiency
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Vascular Diseases
Hydrochlorothiazide
Indapamide
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014