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Completed

NCT Number: NCT01172431

Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indapamide

Drug

Indapamide SR 1.5mg qd

Hydrochlorothiazide

Drug

Hydrochlorothiazide 25mg qd

Primary outcomes

  1. renal function

    Time frame: 1 year

    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 outcomes

  1. endothelial function

    Time frame: 1 year

    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.

  2. blood pressure variability

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 29, 2010
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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