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Bedtime Administration of Amlodipine Versus Lisinopril (BAVLART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01835418
Recruitment Status : Unknown
Verified April 2013 by David Ingham, Allina Health System.
Recruitment status was:  Not yet recruiting
First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
David Ingham, Allina Health System

Tracking Information
First Submitted Date  ICMJE February 21, 2013
First Posted Date  ICMJE April 19, 2013
Last Update Posted Date April 19, 2013
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
Change in mean sleep-time systolic blood pressure after addition of a bedtime dose of amlodipine versus lisinopril [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
  • Changes in mean sleep-time diastolic, awake systolic and diastolic blood pressures, including comparison of % achieving target BP [ Time Frame: 1 year ]
  • Impact of individual medications on sleep-time blood pressure drop (dipping status) [ Time Frame: 1 year ]
  • Association of baseline renin levels to sleep-time blood pressure drop [ Time Frame: 1 year ]
  • Association of baseline renin levels with response to amlodipine versus lisinopril [ Time Frame: 1 year ]
  • Association of baseline dipping status with response to amlodipine versus lisinopril [ Time Frame: 1 year ]
  • Association of age and response to amlodipine versus lisinopril [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bedtime Administration of Amlodipine Versus Lisinopril
Official Title  ICMJE Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial
Brief Summary This study seeks to compare the differences in effectiveness among individual patients treated at for hypertension with bedtime administration of amlodipine versus lisinopril. There will be an analysis of whether one medication was more effective than another and whether specific patient factors could predict who responded better to which one.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: Amlodipine
crossover comparison of amlodipine vs lisinopril
Study Arms  ICMJE
  • Experimental: Lisinopril
    bedtime administration of lisinopril 20mg
    Intervention: Drug: Amlodipine
  • Experimental: Amlodipine
    Bedtime administration of amlodipine 5mg
    Intervention: Drug: Amlodipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 18, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 40 to 80
  • Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor criteria.
  • Minimum Asleep SBP mean of ≥ 120mmHg for inclusion.

Exclusion Criteria:

  • Current antihypertensive medication use
  • Baseline GFR < 45
  • Preexisting macroproteinuria
  • Chronic congestive heart failure
  • History of CVA
  • Diabetes Mellitus
  • Pregnancy
  • Night-shift work
  • Other preexisting contraindication to amlodipine or lisinopril
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01835418
Other Study ID Numbers  ICMJE 9529148100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Ingham, Allina Health System
Study Sponsor  ICMJE Allina Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Allina Health System
Verification Date April 2013

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