Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency
This study is not yet open for participant recruitment.
Verified July 2010 by West China Hospital
Sponsor:
West China Hospital
Information provided by:
West China Hospital
ClinicalTrials.gov Identifier:
NCT01172431
First received: July 26, 2010
Last updated: July 30, 2010
Last verified: July 2010
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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
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172431
Contacts
| Contact: Xiao P Chen, master | 028-85422175 | xiaopingchen11@126.com |
Locations
| China, Sichuan | |
| Department of Cardiology, West China Hospital, Sichuan University | Not yet recruiting |
| Chengdu, Sichuan, China, 610041 | |
| Contact: Xiao P Chen, master 028-85422175 xiaopingchen11@126.com | |
| Principal Investigator: Xiao P Chen, master | |
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, professor, West China Hospital of Sichuan University |
| ClinicalTrials.gov Identifier: | NCT01172431 History of Changes |
| Other Study ID Numbers: | WestChinaH |
| Study First Received: | July 26, 2010 |
| Last Updated: | July 30, 2010 |
| 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 Vascular Diseases Cardiovascular Diseases Kidney Diseases Urologic Diseases Hydrochlorothiazide Indapamide Diuretics |
Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013