Bedtime Administration of Amlodipine Versus Lisinopril (BAVLART)

April 18, 2013 updated by: David Ingham, Allina Health System

Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allina Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (Estimate)

April 19, 2013

Study Record Updates

Last Update Posted (Estimate)

April 19, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9529148100

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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