High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

NCT ID: NCT00242346

Last Updated: 2007-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-12-31

Brief Summary

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The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria.

Detailed Description

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Conditions

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Proteinuria

Keywords

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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candesartan cilexetil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Stable hypertension defined as no new antihypertensive medication started within 6 weeks of Visit 1
* Minimum 6-month history of hypertension and primary glomerular disease
* Hypertensive nephrosclerosis
* Diabetic nephropathy with stable proteinuria as defined by ≥ 1g/24 hours on more than one occasion within 6 months prior to Visit 1

Exclusion Criteria

* Persistent hypertension
* New anti-hypertensive medications started within 6 weeks of Visit 1
* Significant cardiac disease or Liver disease
* Females of childbearing potential without reliable contraception
* Pregnant women and women who are breast-feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kazi Borkowski, PhD

Role: STUDY_DIRECTOR

AstraZeneca

Norman MuirHead, MD

Role: PRINCIPAL_INVESTIGATOR

London HSC

Ellen Burgess, MD

Role: PRINCIPAL_INVESTIGATOR

Foothills Medical Center

Locations

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Research Site

Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Courtice, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Oakville, Ontario, Canada

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Oshawa, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Timmins, Ontario, Canada

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Toronto, Ontario, Canada

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Weston, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Countries

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Canada

References

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Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

Reference Type DERIVED
PMID: 38682786 (View on PubMed)

Cooper TE, Teng C, Tunnicliffe DJ, Cashmore BA, Strippoli GF. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers for adults with early (stage 1 to 3) non-diabetic chronic kidney disease. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD007751. doi: 10.1002/14651858.CD007751.pub3.

Reference Type DERIVED
PMID: 37466151 (View on PubMed)

Burgess E, Muirhead N, Rene de Cotret P, Chiu A, Pichette V, Tobe S; SMART (Supra Maximal Atacand Renal Trial) Investigators. Supramaximal dose of candesartan in proteinuric renal disease. J Am Soc Nephrol. 2009 Apr;20(4):893-900. doi: 10.1681/ASN.2008040416. Epub 2009 Feb 11.

Reference Type DERIVED
PMID: 19211712 (View on PubMed)

Other Identifiers

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DC-AHS-0006

Identifier Type: -

Identifier Source: secondary_id

SMART

Identifier Type: -

Identifier Source: secondary_id

D2452L00006

Identifier Type: -

Identifier Source: org_study_id