ARIA (Atacand Renoprotection In NephropAthy Pt.) - Study Results

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

This study has been completed.

Study NCT00573430 Information provided by AstraZeneca

First Received on December 13, 2007. Last Updated on August 19, 2011 History of Changes

Results First Received: June 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Non-diabetic Nephropathy With Hypertension
Interventions:	Drug: Candesartan Cilexetil Drug: Candesartan Cilexetil 32mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
155 enrolled, 27 screening failure, 128 randomized. Eligibility criteria not fulfilled meant subjects who were not fulfilled at Visit 1 or Enrolment, but screening failure subjects were who fulfilled at Visit 1, but not at Visit 2 after screening period.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 128 patient enrolled, but among of them, 9 subjects excluded from analysis because of Withdrawal by Subject, Protocol violation, Eligibility criteria not fullfiled. You can see these number in above table. This analysis was conducted based on Intend to treat. Therefore, total analyzed number is 119, and 39, 44, 36 per arm respectively.

Reporting Groups

	Description
Candesartan 8 mg	Candesartan 8 mg oral once daily dose
Candesartan 16mg	Candesartan 16mg oral once daily dose
Candesartan 32mg	Candesartan 32mg oral once daily dose

Participant Flow: Overall Study

	Candesartan 8 mg	Candesartan 16mg	Candesartan 32mg
STARTED	40 ^[1]	45 ^[1]	43 ^[1]
COMPLETED	39	40	33
NOT COMPLETED	1	5	10
Incorrect enrollment of randomization	0	4	3
Adverse Event	0	0	2
Withdrawal by Subject	1	0	1
Protocol Violation	0	1	1
Eligibility criteria not fulfilled	0	0	3

[1]	randomized

Baseline Characteristics

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Reporting Groups

	Description
Candesartan 8 mg	Candesartan 8 mg oral once daily dose
Candesartan 16mg	Candesartan 16mg oral once daily dose
Candesartan 32mg	Candesartan 32mg oral once daily dose

Baseline Measures

	Candesartan 8 mg	Candesartan 16mg	Candesartan 32mg	Total
Number of Participants [units: participants]	40	45	43	128
Age [units: years] Mean ± Standard Deviation
19 to 70	45.70 ± 11	46.80 ± 16	49.50 ± 11	47.3 ± 13.4
Gender ^[1] [units: Participants]
Female	20	16	17	53
Male	19	28	19	66

[1]	Analyzed efficacy data and demography data based on Intended to Treat (ITT) set. The discrepancy of “Total” and “Started Period 1” is who is excluded to the ITT set.

Outcome Measures

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1. Primary:

The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks [ Time Frame: baseline to 28 weeks ]

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2. Secondary:

Change of Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: baseline to 28 weeks ]

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3. Secondary:

Inflammatory Marker (Hs-C-peptide Reactive Protein) [ Time Frame: baseline to 28 weeks ]

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4. Secondary:

Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation [ Time Frame: 28 weeks ]

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5. Secondary:

Treatment-emergent Adverse Events [ Time Frame: Baseline to 28 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
phone: +44 7780 956181 ext 5895
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00573430 History of Changes
Other Study ID Numbers:	D2452L00015
Study First Received:	December 13, 2007
Results First Received:	June 17, 2010
Last Updated:	August 19, 2011
Health Authority:	Korea: Food and Drug Administration