High Doses of Candesartan Cilexetil on the Reduction of Proteinuria
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00242346
First received: October 18, 2005
Last updated: December 17, 2007
Last verified: December 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Proteinuria |
Drug: candesartan cilexetil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomised, Dose Ranging, Multi-Centre, Phase IIIb Study to Evaluate the Efficacy and Safety of High Doses of Candesartan Cilexetil (Atacand®) on the Reduction of Proteinuria in the Treatment of Subjects With Hypertension and Moderate to Severe Proteinuria |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection
Secondary Outcome Measures:
- To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance
- To determine the effects of high dose candesartan cilexetil on blood pressure
| Estimated Enrollment: | 270 |
| Study Start Date: | April 2003 |
| Study Completion Date: | December 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242346
Locations
| Canada, Alberta | |
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| Calgary, Alberta, Canada | |
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| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
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| Kelowna, British Columbia, Canada | |
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| Vancouver, British Columbia, Canada | |
| Canada, Manitoba | |
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| Winnipeg, Manitoba, Canada | |
| Canada, Newfoundland and Labrador | |
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| St. John, Newfoundland and Labrador, Canada | |
| Canada, Nova Scotia | |
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| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
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| Courtice, 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, Ontario, Canada | |
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| Sudbury, 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 | |
| Canada, Quebec | |
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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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| Quebec City, Quebec, Canada | |
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| Ste-Foy, Quebec, Canada | |
| Canada, Saskatchewan | |
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| Saskatoon, Saskatchewan, Canada | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Kazi Borkowski, PhD | AstraZeneca |
| Principal Investigator: | Norman MuirHead, MD | London HSC |
| Principal Investigator: | Ellen Burgess, MD | Foothills Medical Center |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00242346 History of Changes |
| Other Study ID Numbers: | D2452L00006, DC-AHS-0006, SMART |
| Study First Received: | October 18, 2005 |
| Last Updated: | December 17, 2007 |
| Health Authority: | Canada: Health Canada |
Keywords provided by AstraZeneca:
|
Hypertension |
Additional relevant MeSH terms:
|
Hypertension Proteinuria Vascular Diseases Cardiovascular Diseases Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Candesartan cilexetil |
Candesartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013