Clinical trial NCT00713011: Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients
Official title: Randomized Open-label 2-arm Parallel Design Comparator Study of the Effect of Adalat® XL® Compared to Diltiazem on Proteinuria and Blood Pressure in Patients With Diabetes and Mild to Moderate Hypertension When Used as an Add on to Avalide®
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetic Nephropathies
Hypertension
Keywords: Adalat XL
Diltiazem
Tiazac XC
Proteinuria
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* \>/= 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Proteinuria
timeFrame: Baseline/Randomization to Week 18
Secondary outcomes:
measure: Percentage of subjects reaching a BP target of 130/80 mmHg at Week 18
timeFrame: Baseline/Randomization to Week 18
measure: Number and doses of anti-hypertensives used in the 2 treatment arms
timeFrame: Baseline/Randomization to Week 18
measure: Levels of urinary albumin and protein content and estimated glomerular filtration rate (GFR) in the 2 treatment groups
timeFrame: Baseline/Randomization to Week 18
measure: Early BP reduction from randomization achieved with the starting dose in the 2 treatment arms
timeFrame: Baseline/Randomization to Week 1
measure: Adverse Events leading to early withdrawal
timeFrame: Screening to end of study
measure: All Adverse Events especially, edema
timeFrame: Screening to end of study
measure: Change in index of glycemia (HbA1c)
timeFrame: Screening to Week 18
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: