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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. 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
Information provided by (Responsible Party):
David Ingham, Allina Health System

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial
Study Start Date : April 2013
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lisinopril
bedtime administration of lisinopril 20mg
Drug: Amlodipine
crossover comparison of amlodipine vs lisinopril

Experimental: Amlodipine
Bedtime administration of amlodipine 5mg
Drug: Amlodipine
crossover comparison of amlodipine vs lisinopril

Primary Outcome Measures :
  1. Change in mean sleep-time systolic blood pressure after addition of a bedtime dose of amlodipine versus lisinopril [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Changes in mean sleep-time diastolic, awake systolic and diastolic blood pressures, including comparison of % achieving target BP [ Time Frame: 1 year ]
  2. Impact of individual medications on sleep-time blood pressure drop (dipping status) [ Time Frame: 1 year ]
  3. Association of baseline renin levels to sleep-time blood pressure drop [ Time Frame: 1 year ]
  4. Association of baseline renin levels with response to amlodipine versus lisinopril [ Time Frame: 1 year ]
  5. Association of baseline dipping status with response to amlodipine versus lisinopril [ Time Frame: 1 year ]
  6. Association of age and response to amlodipine versus lisinopril [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: David Ingham, Physician, Allina Health System Identifier: NCT01835418    
Other Study ID Numbers: 9529148100
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Keywords provided by David Ingham, Allina Health System:
managed with bedtime administration of lisinopril versus amlodipine
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents