Terminated/Withdrawn

Diabetic Nephropathies, Hypertension

Bayer Identifier:

12716

ClinicalTrials.gov Identifier:

NCT00713011

EudraCT Number:

Not Available

EU CT Number:

Not Available

Adalat XL vs diltiazem on proteinuria and blood pressure in hypertensive diabetic patients

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 80 Years

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.

Trial summary

Enrollment Goal

Trial Dates

November 2008 - March 2009

Phase

Phase 3

Could I Receive a placebo

Products

Adalat GITS (Nifedipine, BAYA1040)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Withdrawn	CHUM - Hopital Hotel-Dieu	Montreal, H2W 1T8, Canada
Withdrawn	University of British Columbia	Vancouver, V6H 2Z6, Canada
Withdrawn	London Health Sciences Centre	London, N6A 5A5, Canada
Withdrawn	St. Michael's Hospital Health Centre	Toronto, M5C 2T2, Canada
Withdrawn	Hopital Maisonneuve-Rosemont	Montreal, H1T 2M4, Canada
Withdrawn	Hopital Charles LeMoyne	Greenfield Park, J4V 2H1, Canada
Withdrawn	Co-Medica Research Network, Inc.	Courtice, L1E 3C3, Canada
Withdrawn	Office of Dr. Paul Watson, MD	Thunder Bay, P7E 6E7, Canada
Withdrawn	Ottawa Hospital-Riverside Campus	Ottawa, K1H 7W9, Canada
Withdrawn	University of Alberta Hospital	Edmonton, T6G 2B7, Canada
Withdrawn	Humber River Regional Hospital	Toronto, M3N 1N1, Canada
Withdrawn	St. Paul's Hospital - Vancouver	Vancouver, V6Z 1Y6, Canada
Withdrawn	Oshawa Clinic	Oshawa, L1H 1B9, Canada
Withdrawn	Cape Breton Health Care Complex	Sydney, B1P 1P3, Canada
Withdrawn	Office of Dr. Shivinder Jolly, MD	Kitchener, N2H 5Z8, Canada
Withdrawn	Health Science Centre	Winnipeg, R3A 1R9, Canada
Withdrawn	Sunnybrook Health Sciences Centre	Toronto, M4N 3M5, Canada
Withdrawn	University of Calgary	Calgary, T2N 4N1, Canada
Withdrawn	CHUQ-Hopital Hotel-Dieu de Quebec	Quebec, G1R 2J6, Canada
Withdrawn	Office of Dr. Stephen Chow, MD	Toronto, M4C 5T2, Canada
Withdrawn	Saskatoon Nephrology Group	Saskatoon, S7M 2Z1, Canada

Primary Outcome

Change in Proteinuria
Time Frame:
Baseline/Randomization to Week 18
Safety Issue:
no

Secondary Outcome

Percentage of subjects reaching a BP target of 130/80 mmHg at Week 18
Time Frame:
Baseline/Randomization to Week 18
Safety Issue:
no
Number and doses of anti-hypertensives used in the 2 treatment arms
Time Frame:
Baseline/Randomization to Week 18
Safety Issue:
no
Levels of urinary albumin and protein content and estimated glomerular filtration rate (GFR) in the 2 treatment groups
Time Frame:
Baseline/Randomization to Week 18
Safety Issue:
no
Early BP reduction from randomization achieved with the starting dose in the 2 treatment arms
Time Frame:
Baseline/Randomization to Week 1
Safety Issue:
no
Adverse Events leading to early withdrawal
Time Frame:
Screening to end of study
Safety Issue:
yes
All Adverse Events especially, edema
Time Frame:
Screening to end of study
Safety Issue:
yes
Change in index of glycemia (HbA1c)
Time Frame:
Screening to Week 18
Safety Issue:
no

Trial design

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®

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.