- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01158625
Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Aarhus University Hospital
-
Silkeborg, Denmark, 8600
- Regional Hospital Silkeborg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes
- Systolic nighttime blood pressure above 120 mm Hg
- Systolic daytime blood pressure not exceeding 150 mm Hg
- Antihypertensive treatment which must include
- once-daily drugs
- at least one drug must be a Angiotensin-Converting Enzyme Inhibitor, Angiotensin II Receptor Blocker or Renin Inhibitor.
Exclusion Criteria:
- MI or stroke within 6 months
- heart failure (EF < 45 %)
- atrial fibrillation
- eGFR < 30 ml/min
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Morning dosing of antihypertensive drugs
|
|
Active Comparator: Nighttime dosing of antihypertensive drugs
|
Change of time of administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure, nighttime blood pressure and 24 h blood pressure
Time Frame: After 16 weeks
|
After 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urine albumin excretion
Time Frame: After 16 weeks
|
After 16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Klavs W Hansen, MD, DrMedSc, Department of Medicine, Regional Hospital Silkeborg
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-20100084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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