ARIA (Atacand Renoprotection In NephropAthy Pt.) (PCR)

August 19, 2011 updated by: AstraZeneca

A 28-week, Randomised, Open-label, Parallel-Group, Multi-Center Study To Find the Effective Dose of Candesartan Cilexetil (Atacand) for Renoprotection in Korean Hypertensive Patients With Non-diabetic Nephropathy

To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hypertension; a)135mmHg < Systolic Blood Pressure <180mmHg and/or 85 mmHg < Diastolic Blood Pressure <100 mmHg. or b) The subject has been treated with antihypertensive medication
  • proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)

Exclusion Criteria:

  • Current serum-creatinine > 265 mmol/L (>3 mg/dL).
  • Current serum-potassium > 5.5 mmol/L
  • Known hypersensitivity to angiotensin (AT)1-receptor blocker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Candesartan Cilexetil
Drug: Candesartan Cilexetil
8 mg oral once daily dose
Other Names:
  • Atacand
Drug: Candesartan Cilexetil
16 mg oral once daily dose
Other Names:
  • Atacand
Experimental: 2
Candesartan Cilexetil
Drug: Candesartan Cilexetil
8 mg oral once daily dose
Other Names:
  • Atacand
Drug: Candesartan Cilexetil
16 mg oral once daily dose
Other Names:
  • Atacand
Experimental: 3
Candesartan Cilexetil
Drug: Candesartan Cilexetil 32mg
32 mg oral once daily dose
Other Names:
  • Atacand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
Time Frame: baseline to 28 weeks
Decrease of urinary protein/creatinine ratio means improvement of renal disease.
baseline to 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Systolic and Diastolic Blood Pressure From Baseline
Time Frame: baseline to 28 weeks
baseline to 28 weeks
Inflammatory Marker (Hs-C-peptide Reactive Protein)
Time Frame: baseline to 28 weeks
To evaluate how to reduce and relate with cardiovascular risk
baseline to 28 weeks
Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation
Time Frame: 28 weeks
GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)
28 weeks
Treatment-emergent Adverse Events
Time Frame: Baseline to 28 weeks
Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.
Baseline to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Da Suk Han, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Estimate)

August 23, 2011

Last Update Submitted That Met QC Criteria

August 19, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2452L00015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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