Type 2 Diabetes MellitusPhase 3NCT00362960
Olmesartan Medoxomil and Diabetic Nephropathy
A Phase 3 study testing Olmesartan medoxomil and Losartan in people with Type 2 Diabetes Mellitus and Diabetic Nephropathy, run by Sankyo Pharma Gmbh at 27 sites in 7 countries.
Trial summary
Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Nephropathy, Proteinuria
- What is being tested?
- Olmesartan medoxomil and Losartan
- How many people
- 300 participants
- Where
- 27 sitesin 7 countries
- Study dates
- May 2003to Sep 2004
- Phase
- Phase 3
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female European out-patients
- Greater than or equal to 30 years of age
- Type 2 diabetes first diagnosed at greater than or equal to 30 years of age
- Urinary protein excretion between 200-4000 mg/day exclusive
- Mean sitting dBP less than or equal to 110 mgHg
- Medically justifiable to withdraw antihypertensive treatment due to poor tolerability or inefficacy of previous treatment, or verification that treatment is still necessary
Who cannot join
- Females pregnant, nursing or planning to become pregnant or were of childbearing potential and not using acceptable methods of contraception
- Secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dBP exceeding 110 mmHg or sitting sBP exceeding 200 mmHg
- ECG evidence of 2nd or 3rd degree AV-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia
- Presence of significant cardiovascular disease
- Significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease
- Concurrent renal disease, nephrectomy and/or renal transplant, serum creatinine level greater than or equal to 2.0 mg/dL or creatinine clearance CLCR less than or equal to 50 mL/min
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- Clinically significant lab abnormalities (ASAT/SGOT, ALAT/SGPT and γ-GT )
- Serum potassium level < 2.5 mmol/L or > 5.5 mmol/L
- Treatment of concurrent indications with drugs or medication which could have influenced BP
- History of hypersensitivity, lack of response or contraindication to Ang II-antagonists, HCTZ or atenolol, or hypersensitivity to related drugs (cross-allergy)
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
Poland10 sites
Study site
Grodzisk Mazowiecki
Study site
Krakow
Study site
Płock
Study site
Poznan
Study site
Pruszków
Study site
Torun
Study site
Warsaw
Study site
Watlack
Study site
Wołomin
Study site
Wroclaw
Slovakia7 sites
Study site
Banská Bystrica
Study site
Košice
Study site
Lučenec
Study site
Martin
Study site
Nitra
Study site
Nové Zámky
Study site
Šahy
Germany3 sites
Study site
Augsburg
Study site
Greifenstein-Beilstein
Study site
Hanover
About this study
Official title: Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy
Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy
- Being tested
- Olmesartan medoxomil, Losartan
- Keywords
- Type 2 Diabetes Mellitus, Diabetic Nephropathy, Inflammatory Markers, Proteinuria, Renal Disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies, Proteinuria, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomilDrug
LosartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of olmesartan medoxomil doses compared to losartan in
patients with type 2 diabetes and nephropathy in terms of the change in
proteinuria (total urinary protein excretion) from baseline.
Secondary outcomes (7)
Efficacy of the treatment with olmesartan medoxomil dosages compared to
losartan in patients with type 2 diabetes and nephropathy in terms of
change in:
creatinine clearance (CLCR)
the protein pattern (nephelometry)
inflammatory markers (circulating serum markers).
Evaluate safety and tolerability of all treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startMay 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Sankyo Pharma Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- H Haller, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362960
- Sponsor's protocol ID
- SE-866/29
- Status last verified
- Aug 2006
- First submitted
- 10 Aug 2006
- Last updated
- 9 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy
- ClinicalTrials.gov ID
- NCT00362960
- Acronym / sponsor ID
- SE-866/29
- Keywords
- Type 2 Diabetes Mellitus, Diabetic Nephropathy, Inflammatory Markers, Proteinuria, Renal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Sankyo Pharma GmbhIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Sep 2004
- First posted
- 15 Aug 2006 (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.
Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female European out-patients
- Greater than or equal to 30 years of age
- Type 2 diabetes first diagnosed at greater than or equal to 30 years of age
- Urinary protein excretion between 200-4000 mg/day exclusive
- Mean sitting dBP less than or equal to 110 mgHg
Key exclusion criteria (10 listed)
- Females pregnant, nursing or planning to become pregnant or were of childbearing potential and not using acceptable methods of contraception
- Secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dBP exceeding 110 mmHg or sitting sBP exceeding 200 mmHg
- ECG evidence of 2nd or 3rd degree AV-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia
- Presence of significant cardiovascular disease
- Significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease
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 |
|---|---|---|
| Olmesartan medoxomil | Drug | – |
| Losartan | Drug | – |
Primary outcome
Efficacy of olmesartan medoxomil doses compared to losartan in
patients with type 2 diabetes and nephropathy in terms of the change in
proteinuria (total urinary protein excretion) from baseline.
7 secondary outcomes
Efficacy of the treatment with olmesartan medoxomil dosages compared to
losartan in patients with type 2 diabetes and nephropathy in terms of
change in:
creatinine clearance (CLCR)
the protein pattern (nephelometry)
inflammatory markers (circulating serum markers).
Evaluate safety and tolerability of all treatments.
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 9 Oct 2006.
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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.
H Haller, MD principal investigator
Hannover Medical School
27 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olmesartan medoxomil and Losartan in people with Type 2 Diabetes Mellitus and Diabetic Nephropathy, run by Sankyo Pharma Gmbh at 27 sites in 7 countries.
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 6 inclusion and 10 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 9 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Poland, Slovakia, Czechia, Germany, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy of olmesartan medoxomil doses compared to losartan in. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2006.