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

Primary Purpose

Diabetic Nephropathies, Hypertension

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Adalat XL

Tiazac XC

About this trial

This is an interventional treatment trial for Diabetic Nephropathies focused on measuring Adalat XL, Diltiazem, Tiazac XC, Proteinuria

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Change in Proteinuria

Secondary Outcome Measures

Percentage of subjects reaching a BP target of 130/80 mmHg at Week 18

Number and doses of anti-hypertensives used in the 2 treatment arms

Levels of urinary albumin and protein content and estimated glomerular filtration rate (GFR) in the 2 treatment groups

Early BP reduction from randomization achieved with the starting dose in the 2 treatment arms

Adverse Events leading to early withdrawal

All Adverse Events especially, edema

Change in index of glycemia (HbA1c)

Full Information

NCT ID

NCT00713011

First Posted

July 9, 2008

Last Updated

November 14, 2012

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00713011

Brief Title

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

Acronym

CARDINAL

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®

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Study was stopped by sponsor prior to first patient assignment to groups due to operational reasons.

Study Start Date

November 2008 (undefined)

Primary Completion Date

March 2009 (Anticipated)

Study Completion Date

March 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathies, Hypertension

Keywords

Adalat XL, Diltiazem, Tiazac XC, Proteinuria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Adalat XL

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Tiazac XC

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Proteinuria

Time Frame

Baseline/Randomization to Week 18

Secondary Outcome Measure Information:

Title

Percentage of subjects reaching a BP target of 130/80 mmHg at Week 18

Time Frame

Baseline/Randomization to Week 18

Title

Number and doses of anti-hypertensives used in the 2 treatment arms

Time Frame

Baseline/Randomization to Week 18

Title

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

Title

Early BP reduction from randomization achieved with the starting dose in the 2 treatment arms

Time Frame

Baseline/Randomization to Week 1

Title

Adverse Events leading to early withdrawal

Time Frame

Screening to end of study

Title

All Adverse Events especially, edema

Time Frame

Screening to end of study

Title

Change in index of glycemia (HbA1c)

Time Frame

Screening to Week 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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