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Trial record 82 of 144 for:    NIFEDIPINE

Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients (CARDINAL)

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ClinicalTrials.gov Identifier: NCT00713011
Recruitment Status : Withdrawn (Study was stopped by sponsor prior to first patient assignment to groups due to operational reasons.)
First Posted : July 11, 2008
Last Update Posted : November 16, 2012
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE July 9, 2008
First Posted Date  ICMJE July 11, 2008
Last Update Posted Date November 16, 2012
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2008)
Change in Proteinuria [ Time Frame: Baseline/Randomization to Week 18 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00713011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2008)
  • Percentage of subjects reaching a BP target of 130/80 mmHg at Week 18 [ Time Frame: Baseline/Randomization to Week 18 ]
  • Number and doses of anti-hypertensives used in the 2 treatment arms [ Time Frame: Baseline/Randomization to Week 18 ]
  • 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 ]
  • Early BP reduction from randomization achieved with the starting dose in the 2 treatment arms [ Time Frame: Baseline/Randomization to Week 1 ]
  • Adverse Events leading to early withdrawal [ Time Frame: Screening to end of study ]
  • All Adverse Events especially, edema [ Time Frame: Screening to end of study ]
  • Change in index of glycemia (HbA1c) [ Time Frame: Screening to Week 18 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients
Official Title  ICMJE 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®
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Nephropathies
  • Hypertension
Intervention  ICMJE
  • Drug: Adalat XL
    Patients will receive Avalide (Irbesartan/ hydrochlorothiazide; 300 mg/12.5 mg per day or 300 mg/25.0 mg per day) during the 12 week screening period and during the 18 week treatment period. At baseline, patients will be provided with Adalat XL at a starting dose of 20 or 30 mg. Adalat XL will be titrated during the 18 week treatment period in order to optimize blood pressure. Adalat XL will be supplied in 20 mg, 30 mg, 60 mg, and 90 mg.
  • Drug: Tiazac XC
    Patients will receive Avalide (Irbesartan/ hydrochlorothiazide; 300 mg/12.5 mg per day or 300 mg/25.0 mg per day) during the 12 week screening period and during the 18 week treatment period. At baseline, patients will be provided with Tiazac XC at a starting dose of 180 mg. Tiazac XC will be titrated during the 18 week treatment period in order to optimize blood pressure. Tiazac XC will be supplied in 180 mg, 240 mg, 300 mg and 360 mg.
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Adalat XL
  • Active Comparator: Arm 2
    Intervention: Drug: Tiazac XC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 26, 2010)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2008)
202
Estimated Study Completion Date  ICMJE March 2009
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00713011
Other Study ID Numbers  ICMJE 12716
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Canada
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP