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Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3 (FLIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00565396
Recruitment Status : Unknown
Verified November 2007 by Shanghai Municipal Health Bureau.
Recruitment status was:  Active, not recruiting
First Posted : November 30, 2007
Last Update Posted : November 30, 2007
Sponsor:
Information provided by:
Shanghai Municipal Health Bureau

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Insufficiency Angiotensin-Converting Enzyme Inhibitors Angiotensin II Type 1 Receptor Blockers Proteinuria Drug: Fosinopril and Losartan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center,Double-Blind,Randomized,Controlled Clinical Trial of Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
Study Start Date : September 2004
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: 1
Fosinopril 10mg/day(oral)
Drug: Fosinopril and Losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

Active Comparator: 2
Fosinopril 20mg/day(oral)
Drug: Fosinopril and Losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

Active Comparator: 3
Losartan 50mg/day(oral)
Drug: Fosinopril and Losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)

Active Comparator: 4
Losartan 100mg/day(oral)
Drug: Fosinopril and Losartan
Fosinopril 10mg/day(oral) Losartan 50mg/day(oral)




Primary Outcome Measures :
  1. progress to End Stage Renal Disease [ Time Frame: within two years ]
  2. double of serum creatinine [ Time Frame: within two years ]
  3. all cause mortality [ Time Frame: within two years ]

Secondary Outcome Measures :
  1. decreased proteinuria [ Time Frame: within two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565396


Locations
Show Show 26 study locations
Sponsors and Collaborators
Shanghai Municipal Health Bureau
Investigators
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Study Chair: Nan Chen, M.D. Ruijin Hospital
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Responsible Party: Nan Chen, Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
ClinicalTrials.gov Identifier: NCT00565396    
Other Study ID Numbers: 2003ZD002
2003ZD002
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: November 2007
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Proteinuria
Renal Insufficiency
Urologic Diseases
Urination Disorders
Urological Manifestations
Losartan
Fosinopril
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors