Type 2 Diabetes MellitusPhase 4NCT00407680
Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension
A Phase 4 study testing Intensive therapy Valsartan,Fluvastatin in people with Type 2 Diabetes Mellitus and Hypertension, run by Kitasato University at 1 site in Japan.
Trial summary
To observe the effect of intensive medical treatment for type 2 diabetic patients with hypertension: to discover whether or not intensive medical treatment improves proteinuria, and the difference between the clinical meaning of responder and non-responder (criteria: 50% reduced proteinuria continuing 6 months or more… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- Intensive therapy Valsartan,Fluvastatin
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2006to Mar 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients with hypertension, with all 5 of the criteria listed below:
- Age 20 years and above
- Blood pressure >125/75 mmHg
- Urinary protein creatinine ratio 1g/g・cr or Urinary protein >1 g/day
- Presence of diabetic retinopathy
- Already performing dietary management
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- There were no limitations on serum creatinine.
- BP was recorded 3 times while the patient was seated and averaged.
- The subjects in this study were outpatients with written informed consent.
Who cannot join
- Another definable renal disease other than DN
- Collagenosis
- Malignant hypertension with emergent treatment
- Severe hypertension (diastolic BP >120 mmHg)
- Severe chronic heart failure or acute myocardial infarction in the past 6 months
- Atrial fibrillation or severe arrhythmia
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- Anamnesis of cerebrovascular disease with neuropathy
- Anamnesis of anaphylaxis or chronic dermatopathy
- Severe hepatic disease
- Pregnancy
- Anamnesis of anaphylaxis from angiotensin II receptor blocker
- Patients are judged to be inapposite by the attending physician
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kitasato University
1-15-1 Kitasato Sagamihara, Kanagawa, 228-8111
Keiji Tanaka, +81-427-8111 ext. 8706, keiji@med.kitasato-u.ac.jp
Keiji Tanaka, Keiji Tanaka
About this study
To observe the effect of intensive medical treatment for type 2 diabetic patients with hypertension: to discover whether or not intensive medical treatment improves proteinuria, and the difference between the clinical meaning of responder and non-responder (criteria: 50% reduced proteinuria continuing 6 months or more during the observation period.)
Read the detailed description
It is reported that the risk of a cardiovascular event occurring is 1.78 times higher in patients with diabetic nephropathy (DN) than in patients without DN. It is also reported that angiotensin II receptor blockade (ARB) prevents the progression of DN in diabetic patients with early phase nephropathy beyond its blood pressure lowering effect. The guidelines by the Japanese Society of Hypertension 2004 recommended that it was necessary to control blood pressure (BP) below 130/80 mmHg in all diabetic patients. This has become the universal target BP for the prevention of cardiovascular events in hypertensive patients. On the study of intensive medical treatment [including angiotensin-converting enzyme inhibitor (ACEI)], it is reported that ACEI not only prevents the progression of DN in microalbuminuria but also decreases proteinuria <1 g/day in the nephrotic syndrome. Therefore, ACEI is thought to be effective for DN. However, it is not clear whether or not intensive medical treatment (including ACEI) improves nephropathy with proteinuria >1 g/day.
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Being tested
- Intensive therapy Valsartan,Fluvastatin
- Keywords
- Type 2 diabetes mellitus, Hypertension, Angiotensin II Receptor Blocker, Diabetic nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive therapy Valsartan,FluvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteinuria
Serum Creatinine
e-GFR
Fasting Plasma Glucose
HbA1c
Secondary outcomes (6)
Lipid profile
Blood pressure
Smoking
Progression of renal dysfunction
Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin
Serum angiotensinogen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startOct 2006
- Study completionMar 2009 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kitasato University
- Sponsor type
- University, hospital or other
- Collaborators
- Tokai University, Yokohama City University Medical Center, St. Marianna University School of Medicine
- Investigators
- Keiji Tanaka, MD,PhD, Study chair, Kitasato University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407680
- Sponsor's protocol ID
- 8417
- Status last verified
- Oct 2007
- First submitted
- 4 Dec 2006
- Last updated
- 23 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension
- ClinicalTrials.gov ID
- NCT00407680
- Acronym / sponsor ID
- 8417
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Keywords
- Type 2 diabetes mellitus, Hypertension, Angiotensin II Receptor Blocker, Diabetic nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kitasato UniversityUniversity, hospital or other
- Collaborators
- Tokai University, Yokohama City University Medical Center, St. Marianna University School of Medicine
- Study start
- Oct 2006
- Study completion
- Mar 2009 (estimated)
- First posted
- 5 Dec 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.
To observe the effect of intensive medical treatment for type 2 diabetic patients with hypertension: to discover whether or not intensive medical treatment improves proteinuria, and the difference between the clinical meaning of responder and non-responder (criteria: 50% reduced proteinuria continuing 6 months or more during the observation period.)
Detailed description
It is reported that the risk of a cardiovascular event occurring is 1.78 times higher in patients with diabetic nephropathy (DN) than in patients without DN. It is also reported that angiotensin II receptor blockade (ARB) prevents the progression of DN in diabetic patients with early phase nephropathy beyond its blood pressure lowering effect. The guidelines by the Japanese Society of Hypertension 2004 recommended that it was necessary to control blood pressure (BP) below 130/80 mmHg in all diabetic patients. This has become the universal target BP for the prevention of cardiovascular events in hypertensive patients. On the study of intensive medical treatment [including angiotensin-converting enzyme inhibitor (ACEI)], it is reported that ACEI not only prevents the progression of DN in microalbuminuria but also decreases proteinuria <1 g/day in the nephrotic syndrome. Therefore, ACEI is thought to be effective for DN. However, it is not clear whether or not intensive medical treatment (including ACEI) improves nephropathy with proteinuria >1 g/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 20 years and above
- Blood pressure >125/75 mmHg
- Urinary protein creatinine ratio 1g/g・cr or Urinary protein >1 g/day
- Presence of diabetic retinopathy
- Already performing dietary management
Key exclusion criteria (12 listed)
- Another definable renal disease other than DN
- Collagenosis
- Malignant hypertension with emergent treatment
- Severe hypertension (diastolic BP >120 mmHg)
- Severe chronic heart failure or acute myocardial infarction in the past 6 months
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 |
|---|---|---|
| Intensive therapy Valsartan,Fluvastatin | Drug | – |
Primary outcome
Proteinuria
Serum Creatinine
e-GFR
Fasting Plasma Glucose
HbA1c
6 secondary outcomes
Lipid profile
Blood pressure
Smoking
Progression of renal dysfunction
Urinary 8-OHdG,type 4 collagen,high molecular weight adiponectin
Serum angiotensinogen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2007.
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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.
Keiji Tanaka, MD,PhD study chair
Kitasato University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intensive therapy Valsartan,Fluvastatin in people with Type 2 Diabetes Mellitus and Hypertension, run by Kitasato University at 1 site in Japan.
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keiji Tanaka, MD,PhD (+81-427-778-8111 ext. 8706, keiji@med.kitasato-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteinuria. The study lists 5 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 23 Oct 2007.