NCT01158625

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

2.3 years

First QC Date

June 25, 2010

Last Update Submit

April 3, 2013

Conditions

Diabetes Mellitus, Type 2Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure, nighttime blood pressure and 24 h blood pressure

    After 16 weeks

Secondary Outcomes (1)

  • Urine albumin excretion

    After 16 weeks

Study Arms (2)

Morning dosing of antihypertensive drugs

NO INTERVENTION

Nighttime dosing of antihypertensive drugs

ACTIVE COMPARATOR
Other: Change of time of administration

Interventions

Change of time of administrationOTHER

Change of time of administration

Nighttime dosing of antihypertensive drugs

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • MI or stroke within 6 months
  • heart failure (EF \< 45 %)
  • atrial fibrillation
  • eGFR \< 30 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Regional Hospital Silkeborg

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Klavs W Hansen, MD, DrMedSc

    Department of Medicine, Regional Hospital Silkeborg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2010

First Posted

July 8, 2010

Study Start

August 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

DK(2)