Bedtime Administration of Amlodipine Versus Lisinopril

Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01835418

Acronym

BAVLART

Enrollment

100

Registered

2013-04-19

Start date

2013-04-30

Completion date

Unknown

Last updated

2013-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

managed with bedtime administration of lisinopril versus amlodipine

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.

Interventions

DRUGAmlodipine

crossover comparison of amlodipine vs lisinopril

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026