- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00565396
Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3 (FLIP)
November 29, 2007 updated by: Shanghai Municipal Health Bureau
Multi-Center,Double-Blind,Randomized,Controlled Clinical Trial of Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
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
-
-
-
Shanghai, China, 200433
- Changhai Hospital
-
Shanghai, China, 200233
- Shanghai 6th People's Hospital
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Shanghai, China, 200032
- ZhongShan Hospital
-
Shanghai, China, 200072
- Shanghai 10th People's Hospital
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Shanghai, China, 200092
- Xinhua Hospital
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Shanghai, China, 200001
- Renji Hospital
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Shanghai, China, 200003
- Changzheng hospital
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Shanghai, China, 200011
- Shanghai 9th People's Hospital
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Shanghai, China, 200025
- Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
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Shanghai, China, 200040
- Huadong Hospital
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Shanghai, China, 200040
- Huashan
-
Shanghai, China, 200052
- Shanghai 455 Hospital
-
Shanghai, China, 200052
- Shanghai 85 Hospital
-
Shanghai, China, 200065
- Tongji Hospital
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Shanghai, China, 200080
- Shanghai 1st People's Hospital
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Shanghai, China, 200090
- Shanghai Yangpu District Centre Hospital
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Shanghai, China, 200120
- Shanghai East Hospital
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Shanghai, China, 200336
- Shanghai Changning District Centre Hospital
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Jiangsu
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Taizhou, Jiangsu, China, 225300
- Taizhou People's Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The 1st Affiliated Hospital of College of Medicine, Zhejiang University
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Hangzhou, Zhejiang, China, 310007
- Guangxing Hospital
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Hangzhou, Zhejiang, China, 310016
- Shaoyifu Hospital
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Ningbo, Zhejiang, China, 315000
- Ningbo Lihuili Hospital
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Wenling, Zhejiang, China, 317500
- Wenling 1st People's Hospital
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Wenzhou, Zhejiang, China, 325000
- The First Affiliated Hospital Of WenZhou Medical College
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Xiangshan, Zhejiang, China, 315700
- Xiangshan People's Hospital
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-
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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 18-75 years old
- Roll out secondary renal diseases
- Do not use steroids and immunosuppresive drugs
- ACEI/ARB treated patients should have 7-14 days wash out period,SiDBP< 110mmHg
- Willing and able to comprehend and give written informed consent
- Willing to follow-up regularly
Exclusion Criteria:
- Use steroids and immunosuppresive drugs
- Secondary renal diseases
- Acute cardio-cerebral diseases within 6 months
- Post renal transplantation
- Pregnant/Nursing women
- History of hypersensitivity to ACEI/ARB
- Refuse to join clinical trial
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Fosinopril 10mg/day(oral)
|
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
|
Active Comparator: 2
Fosinopril 20mg/day(oral)
|
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
|
Active Comparator: 3
Losartan 50mg/day(oral)
|
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
|
Active Comparator: 4
Losartan 100mg/day(oral)
|
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progress to End Stage Renal Disease
Time Frame: within two years
|
within two years
|
double of serum creatinine
Time Frame: within two years
|
within two years
|
all cause mortality
Time Frame: within two years
|
within two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
decreased proteinuria
Time Frame: within two years
|
within two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nan Chen, M.D., Ruijin 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
September 1, 2004
Study Completion (Anticipated)
July 1, 2008
Study Registration Dates
First Submitted
November 28, 2007
First Submitted That Met QC Criteria
November 29, 2007
First Posted (Estimate)
November 30, 2007
Study Record Updates
Last Update Posted (Estimate)
November 30, 2007
Last Update Submitted That Met QC Criteria
November 29, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urological Manifestations
- Urination Disorders
- Kidney Diseases
- Renal Insufficiency, Chronic
- Proteinuria
- Renal Insufficiency
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Angiotensin-Converting Enzyme Inhibitors
- Losartan
- Fosinopril
Other Study ID Numbers
- 2003ZD002
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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