Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency
Information source: West China Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Renal Insufficiency
Intervention: Indapamide (Drug); Hydrochlorothiazide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: West China Hospital Official(s) and/or principal investigator(s): Xiao P Chen, master, Principal Investigator, Affiliation: West China Hospital
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: renal function
Secondary outcome: endothelial functionblood pressure variability
Eligibility
Minimum age: 65 Years.
Maximum age: 85 Years.
Gender(s): Both.
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.
Locations and Contacts
Department of Cardiology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
Additional Information
Starting date: September 2010
Last updated: June 23, 2014
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