Trials / Unknown
UnknownNCT00407680
Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Kitasato University · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intensive therapy Valsartan,Fluvastatin |
Timeline
- Start date
- 2006-10-01
- Completion
- 2009-03-01
- First posted
- 2006-12-05
- Last updated
- 2007-10-23
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00407680. Inclusion in this directory is not an endorsement.