Status:
WITHDRAWN
Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients
Lead Sponsor:
Bayer
Conditions:
Diabetic Nephropathies
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The study consists of a 12 week run-in period when all subjects are stabilized on a single dose of Avalide (300 mg/12.5 mg or 300mg/25mg dose) per day. After this 12 week run-in ends, subjects will be...
Eligibility Criteria
Inclusion
- \>/= 18 and \< 80 years old.
- Diagnosed with hypertension.
- Diagnosed with diabetes mellitus type 2 for at least 6 mths prior to entry and on stable medication for diabetes for at 1 mth prior to screening.
- Treated on ARB, ACE inhibitor with or without hydrochlorothiazide and suitable to receive combination therapy with Avalide at 300mg/12.5mg per day or 300mg/25mg per day.
- Diagnosed with diabetic nephropathy and have proteinuria between 0.8g/day and 5.0g/day at screening and then between 0.8g/day and 3.0g/day at randomization.
- Medically appropriate to receive Adalat XL or Tiazac XC.
Exclusion
- History of alcohol or substance abuse.
- Significant CV disorder such as ischemic heart disease, arrhythmias within the last 6 mths, or any history of severe congestive heart failure.
- Myocarditis or pericarditis within last 30 day of screening.
- ECG showing evidence of major arrhythmia or conduction disturbances requiring treatment with anti-arrhythmic medication.
- Females with child-bearing potential or males with a partner of child-bearing potential unless willing to use effective contraception during the study and 3 mths after the end of study.
- Females who are pregnant, lactating or planning pregnancy during the study and for 3 mths after the study end.
- Known hypersensitivity to Adalat XL or Tiazac XC or other calcium channel blockers of the dihydropyridine class.
- Resting heart rate \<50 or \>110 bpm.
- Presence of secondary or malignant hypertension.
- DBP \>/= 180 and/or SBP \>/= 110 mmHg.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00713011
Start Date
November 1 2008
End Date
March 1 2009
Last Update
November 16 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.