Diabetic NephropathiesPhase 3CARDINALNCT00713011
Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients
A Phase 3 study testing Adalat XL and Tiazac XC in people with Diabetic Nephropathies and Hypertension, run by Bayer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathies, Hypertension
- What is being tested?
- Adalat XL and Tiazac XC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Mar 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >/= 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
About this study
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®
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.
- Conditions
- Diabetic Nephropathies, Hypertension
- Being tested
- Adalat XL, Tiazac XC
- Keywords
- Adalat XL, Diltiazem, Tiazac XC, Proteinuria
- Medical subject headings
- Diabetic Nephropathies, Hypertension, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalat XLDrug
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.
Tiazac XCDrug
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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Adalat XL |
| Arm 2 | Active comparator | Not described Receives: Drug: Tiazac XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proteinuria
Measured: Baseline/Randomization to Week 18
Secondary outcomes (7)
Percentage of subjects reaching a BP target of 130/80 mmHg at Week 18
Measured: Baseline/Randomization to Week 18
Number and doses of anti-hypertensives used in the 2 treatment arms
Measured: Baseline/Randomization to Week 18
Levels of urinary albumin and protein content and estimated glomerular filtration rate (GFR) in the 2 treatment groups
Measured: Baseline/Randomization to Week 18
Early BP reduction from randomization achieved with the starting dose in the 2 treatment arms
Measured: Baseline/Randomization to Week 1
Adverse Events leading to early withdrawal
Measured: Screening to end of study
All Adverse Events especially, edema
Measured: Screening to end of study
Change in index of glycemia (HbA1c)
Measured: Screening to Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Why it stopped: Study was stopped by sponsor prior to first patient assignment to groups due to operational reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713011
- Sponsor's protocol ID
- 12716
- Acronym
- CARDINAL
- Status last verified
- Nov 2012
- First submitted
- 9 Jul 2008
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®
- ClinicalTrials.gov ID
- NCT00713011
- Acronym / sponsor ID
- CARDINAL / 12716
- Conditions
- Diabetic Nephropathies, Hypertension
- Keywords
- Adalat XL, Diltiazem, Tiazac XC, Proteinuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was stopped by sponsor prior to first patient assignment to groups due to operational reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Adalat XL |
| Arm 2 | Active comparator | Drug: Tiazac XC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >/= 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalat XLPatients 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 | Arm 1 |
| Tiazac XCPatients 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. | Drug | Arm 2 |
Primary outcome
Change in Proteinuria
Time frame: Baseline/Randomization to Week 18
7 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
Related trials for Diabetic Nephropathies
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalat XL and Tiazac XC in people with Diabetic Nephropathies and Hypertension, run by Bayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proteinuria (time frame: Baseline/Randomization to Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2012.