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Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Regionshospitalet Silkeborg
The Ministry of Science, Technology and Innovation, Denmark
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01158625
First received: June 25, 2010
Last updated: April 3, 2013
Last verified: April 2013

June 25, 2010
April 3, 2013
August 2010
November 2012   (final data collection date for primary outcome measure)
Blood pressure, nighttime blood pressure and 24 h blood pressure [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01158625 on ClinicalTrials.gov Archive Site
Urine albumin excretion [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes
Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

The purpose of this study is to investigate if it is possible to lower the nighttime blood pressure in patients with type 2 diabetes mellitus by shifting the administration of antihypertensive drugs from morning to nighttime.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Hypertension
Other: Change of time of administration
Change of time of administration
  • No Intervention: Morning dosing of antihypertensive drugs
  • Active Comparator: Nighttime dosing of antihypertensive drugs
    Intervention: Other: Change of time of administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01158625
M-20100084
No
University of Aarhus
University of Aarhus
  • Regionshospitalet Silkeborg
  • The Ministry of Science, Technology and Innovation, Denmark
  • Central Denmark Region
Study Director: Klavs W Hansen, MD, DrMedSc Department of Medicine, Regional Hospital Silkeborg
University of Aarhus
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP