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OpenTrials
Completed

NCT Number: NCT00573430

ARIA (Atacand Renoprotection In NephropAthy Pt.)

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

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Key information

Conditions

Non-diabetic Nephropathy With Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candesartan cilexetil

Drug

8 mg oral once daily dose

Other names: Atacand

Candesartan Cilexetil 32mg

Drug

32 mg oral once daily dose

Other names: Atacand

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change of Systolic and Diastolic Blood Pressure From Baseline

    Time frame: baseline to 28 weeks

  2. Inflammatory Marker (Hs-C-peptide Reactive Protein)

    Time frame: baseline to 28 weeks

    To evaluate how to reduce and relate with cardiovascular risk

  3. 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)

  4. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PCR

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 14, 2007
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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