Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172431
• Other study ID #: WestChinaH
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2010
• Last updated: June 23, 2014
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Renal Insufficiency

Intervention

Drug:
• Indapamide
Indapamide SR 1.5mg qd
• Hydrochlorothiazide
Hydrochlorothiazide 25mg qd

Locations

Country	Name	City	State
China	Department of Cardiology, West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	1 year	Yes
Secondary	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	1 year	Yes