Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

NCT01172431 | Completed Phase 4 DMC

• 1 other identifier: WestChinaH
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Renal Insufficiency

Keywords

hypertension; renal insufficiency; indapamide; hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• endothelial function

  1 year

• blood pressure variability

  1 year

Study Arms (2)

Indapamide

EXPERIMENTAL

Indapamide SR 1.5mg qd

Drug: Indapamide

Hydrochlorothiazide

ACTIVE COMPARATOR

Hydrochlorothiazide 25mg qd

Drug: Hydrochlorothiazide

Interventions

Indapamide DRUG

Indapamide SR 1.5mg qd

Indapamide

Hydrochlorothiazide DRUG

Hydrochlorothiazide 25mg qd

Hydrochlorothiazide

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Department of Cardiology, West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Hypertension; Renal Insufficiency

Interventions

Indapamide; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiao P Chen, master

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xiaoping Chen, professor, West China Hospital of Sichuan University.

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 29, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

CN (1)