stop_circleTerminated/Withdrawn
Diabetic Nephropathies, Hypertension
Bayer Identifier:
12716
ClinicalTrials.gov Identifier:
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
BothAge
18 - 80 YearsTrial summary
Enrollment Goal
0Trial Dates
November 2008 - March 2009Phase
Phase 3Could I Receive a placebo
NoProducts
Adalat GITS (Nifedipine, BAYA1040)Accepts Healthy Volunteer
NoWhere 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Withdrawn | CHUM - Hopital Hotel-Dieu | Montreal, H2W 1T8, Canada |
Withdrawn | University of British Columbia | Vancouver, V6H 2Z6, Canada |
Withdrawn | London Health Sciences Centre | London, N6A 5A5, Canada |
Withdrawn | St. Michael's Hospital Health Centre | Toronto, M5C 2T2, Canada |
Withdrawn | Hopital Maisonneuve-Rosemont | Montreal, H1T 2M4, Canada |
Withdrawn | Hopital Charles LeMoyne | Greenfield Park, J4V 2H1, Canada |
Withdrawn | Co-Medica Research Network, Inc. | Courtice, L1E 3C3, Canada |
Withdrawn | Office of Dr.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Withdrawn | Ottawa Hospital-Riverside Campus | Ottawa, K1H 7W9, Canada |
Withdrawn | University of Alberta Hospital | Edmonton, T6G 2B7, Canada |
Withdrawn | Humber River Regional Hospital | Toronto, M3N 1N1, Canada |
Withdrawn | St. Paul's Hospital - Vancouver | Vancouver, V6Z 1Y6, Canada |
Withdrawn | Oshawa Clinic | Oshawa, L1H 1B9, Canada |
Withdrawn | Cape Breton Health Care Complex | Sydney, B1P 1P3, Canada |
Withdrawn | Office of Dr.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Withdrawn | Health Science Centre | Winnipeg, R3A 1R9, Canada |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 Proteinuriadate_rangeTime Frame:Baseline/Randomization to Week 18enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Percentage of subjects reaching a BP target of 130/80 mmHg at Week 18date_rangeTime Frame:Baseline/Randomization to Week 18enhanced_encryptionnoSafety Issue:
- Number and doses of anti-hypertensives used in the 2 treatment armsdate_rangeTime Frame:Baseline/Randomization to Week 18enhanced_encryptionnoSafety Issue:
- Levels of urinary albumin and protein content and estimated glomerular filtration rate (GFR) in the 2 treatment groupsdate_rangeTime Frame:Baseline/Randomization to Week 18enhanced_encryptionnoSafety Issue:
- Early BP reduction from randomization achieved with the starting dose in the 2 treatment armsdate_rangeTime Frame:Baseline/Randomization to Week 1enhanced_encryptionnoSafety Issue:
- Adverse Events leading to early withdrawaldate_rangeTime Frame:Screening to end of studyenhanced_encryptionyesSafety Issue:
- All Adverse Events especially, edemadate_rangeTime Frame:Screening to end of studyenhanced_encryptionyesSafety Issue:
- Change in index of glycemia (HbA1c)date_rangeTime Frame:Screening to Week 18enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2