Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients (CARDINAL)
This study has been withdrawn prior to enrollment.
(Study was stopped by sponsor prior to first patient assignment to groups due to operational reasons.)
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00713011
First received: July 9, 2008
Last updated: November 14, 2012
Last verified: November 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Nephropathies Hypertension |
Drug: Adalat XL Drug: Tiazac XC |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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® |
Resource links provided by NLM:
Drug Information available for:
Verapamil hydrochloride
Nifedipine
Diltiazem hydrochloride
Diltiazem
Diltiazem malate
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Change in Proteinuria [ Time Frame: Baseline/Randomization to Week 18 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of subjects reaching a BP target of 130/80 mmHg at Week 18 [ Time Frame: Baseline/Randomization to Week 18 ] [ Designated as safety issue: No ]
- Number and doses of anti-hypertensives used in the 2 treatment arms [ Time Frame: Baseline/Randomization to Week 18 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
- Adverse Events leading to early withdrawal [ Time Frame: Screening to end of study ] [ Designated as safety issue: Yes ]
- All Adverse Events especially, edema [ Time Frame: Screening to end of study ] [ Designated as safety issue: Yes ]
- Change in index of glycemia (HbA1c) [ Time Frame: Screening to Week 18 ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
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.
|
| Active Comparator: Arm 2 |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Canada |
| ClinicalTrials.gov Identifier: | NCT00713011 History of Changes |
| Other Study ID Numbers: | 12716 |
| Study First Received: | July 9, 2008 |
| Last Updated: | November 14, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Bayer:
|
Adalat XL Diltiazem Tiazac XC Proteinuria |
Additional relevant MeSH terms:
|
Diabetic Nephropathies Hypertension Kidney Diseases Proteinuria Urologic Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Urination Disorders Urological Manifestations Signs and Symptoms Diltiazem |
Verapamil Nifedipine Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Vasodilator Agents Anti-Arrhythmia Agents Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013