Loading clinical trials...

Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

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®

NCT00713011•Bayer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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.

Key Dates

Start Date

November 1, 2008

Primary Completion Date

March 1, 2009

Completion Date

March 1, 2009

Last Updated

November 16, 2012

Conditions

Diabetic NephropathiesHypertension

Interventions

Adalat XL

DRUG

Tiazac XC

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

Penn Medicine Healthy Heart

Preliminary Human Trials of F230 Tablets