Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01158625|
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : April 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Hypertension||Other: Change of time of administration||Not Applicable|
In recent years several studies have shown that high nighttime blood pressure is associated with increased cardiovascular risk independently of the average 24 hour blood pressure. As a consequence there has been increasing focus on nighttime blood pressure and how to lower it. One way of addressing the problem is to shift the administration of antihypertensive drugs from morning to nighttime. Studies on non-diabetic patients show that by doing this the nighttime blood pressure can be lowered with 3-5 mm Hg without negative effect on the 24 hour blood pressure.
Only recently a study was made on diabetic patients. This showed similar results as for non-diabetic patients.However this study was based on diabetic patients who did not receive any antihypertensive drugs before.
This study will investigate the effects on nighttime blood pressure when shifting administration of antihypertensive drugs from morning to nighttime. The population is diabetic patients who are already in antihypertensive treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
|No Intervention: Morning dosing of antihypertensive drugs|
|Active Comparator: Nighttime dosing of antihypertensive drugs||
Other: Change of time of administration
Change of time of administration
- Blood pressure, nighttime blood pressure and 24 h blood pressure [ Time Frame: After 16 weeks ]
- Urine albumin excretion [ Time Frame: After 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158625
|Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Regional Hospital Silkeborg|
|Silkeborg, Denmark, 8600|
|Study Director:||Klavs W Hansen, MD, DrMedSc||Department of Medicine, Regional Hospital Silkeborg|