Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients
Withdrawn
Bayer
Phase 3
2008-11-01
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 randomly assigned to start the addition of either Adalat XL or Tiazac XC for
18 weeks of treatment. Subjects will have a 1 in 2 chance of receiving the study drug Adalat
XL and a 1 in 2 chance of receiving the drug Tiazac XC. An end of treatment visit will be
done 18 weeks after start of study drug. The expected duration of the study is 30 weeks. The
purpose of this study is to compare the change in proteinuria, through a urine test, while
taking study drug until high blood pressure (BP) is reduced to near normal levels in study
subjects with diabetic nephropathy and hypertension.
Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions
Completed
Roxane Laboratories
N/A
2007-09-01
The objective of this study was to prove the bioequivalence of Roxane Laboratories'
Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions
Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions
Completed
Roxane Laboratories
N/A
2007-09-01
The objective of this study was to prove the bioequivalence of Roxane Laboratories'
Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fasted conditions.
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