Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00713011

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 III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems High Blood Pressure Urine and Urination

Drug Information available for: Verapamil Nifedipine Diltiazem hydrochloride Dexverapamil Diltiazem Diltiazem malate Verapamil hydrochloride

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
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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713011

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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:	February 26, 2010
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 February 12, 2012