Renal DisorderPhase 4NCT00140985
Antiproteinuric Efficacy of Losartan Potassium in Patients With Non-Diabetic Proteinuric Renal Diseases (0954-213)
A Phase 4 study testing MK0954, losartan potassium/Duration of Treatment: 20 weeks and Comparator: amlodipine / Duration of Treatment: 20 weeks in people with Renal Disorder, run by Organon and Co.
Trial summary
Antiproteinuric Efficacy of Losartan Potassium in Patients with Non-Diabetic Proteinuric Renal Diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disorder
- What is being tested?
- MK0954, losartan potassium/Duration of Treatment: 20 weeks and Comparator: amlodipine / Duration of Treatment: 20 weeks
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Jan 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females at least 18 years of age with non-diabetic proteinuric renal diseases
Who cannot join
None listed.
About this study
Official title: A Randomized, Parallel, Double Blind Study of Losartan Versus Amlodipine in Patients With Mild to Moderate Hypertension and Chronic Nondiabetic Proteinuric Nephropathy: Evaluation of the Effect on Proteinuria and on the Plasmatic Levels of Growth Factors (TGFß and VEGF)
Antiproteinuric Efficacy of Losartan Potassium in Patients with Non-Diabetic Proteinuric Renal Diseases.
- Conditions
- Renal Disorder
- Being tested
- MK0954, losartan potassium/Duration of Treatment: 20 weeks, Comparator: amlodipine / Duration of Treatment: 20 weeks
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0954, losartan potassium/Duration of Treatment: 20 weeksDrug
Comparator: amlodipine / Duration of Treatment: 20 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
24h proteinuria
Secondary outcomes (1)
Changes in the plasma and urinary levels of TGF-beta
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startFeb 2000
- Primary completionJan 2002
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140985
- Sponsor's protocol ID
- 0954-213
- Other IDs
- MK0954-213, 2005_058
- Status last verified
- Feb 2022
- First submitted
- 30 Aug 2005
- Last updated
- 16 Feb 2022
- Results posted
- No
Publications
Praga M, Andrade CF, Luno J, Arias M, Poveda R, Mora J, Prat MV, Rivera F, Galceran JM, Ara JM, Aguirre R, Bernis C, Marin R, Campistol JM. Antiproteinuric efficacy of losartan in comparison with amlodipine in non-diabetic proteinuric renal diseases: a double-blind, randomized clinical trial. Nephrol Dial Transplant. 2003 Sep;18(9):1806-13. doi: 10.1093/ndt/gfg284.
PubMed 12937228
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Double Blind Study of Losartan Versus Amlodipine in Patients With Mild to Moderate Hypertension and Chronic Nondiabetic Proteinuric Nephropathy: Evaluation of the Effect on Proteinuria and on the Plasmatic Levels of Growth Factors (TGFß and VEGF)
- ClinicalTrials.gov ID
- NCT00140985
- Acronym / sponsor ID
- 0954-213
- Conditions
- Renal Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Jan 2002 (actual)
- Study completion
- Jan 2002 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antiproteinuric Efficacy of Losartan Potassium in Patients with Non-Diabetic Proteinuric Renal Diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males or females at least 18 years of age with non-diabetic proteinuric renal diseases
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK0954, losartan potassium/Duration of Treatment: 20 weeks | Drug | – |
| Comparator: amlodipine / Duration of Treatment: 20 weeks | Drug | – |
Primary outcome
24h proteinuria
1 secondary outcome
Changes in the plasma and urinary levels of TGF-beta
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Results publication: PubMed 12937228Praga M, Andrade CF, Luno J, Arias M, Poveda R, Mora J, Prat MV, Rivera F, Galceran JM, Ara JM, Aguirre R, Bernis C, Marin R, Campistol JM. Antiproteinuric efficacy of losartan in comparison with amlodipine in non-diabetic proteinuric renal diseases: a double-blind, randomized clinical trial. Nephrol Dial Transplant. 2003 Sep;18(9):1806-13. doi: 10.1093/ndt/gfg284.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MK0954, losartan potassium/Duration of Treatment: 20 weeks and Comparator: amlodipine / Duration of Treatment: 20 weeks in people with Renal Disorder, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24h proteinuria. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00140985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.