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Bedtime Administration of Amlodipine Versus Lisinopril

Information source: Allina Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Amlodipine (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Allina Health System


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.

Clinical Details

Official title: Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in mean sleep-time systolic blood pressure after addition of a bedtime dose of amlodipine versus lisinopril

Secondary outcome:

Changes in mean sleep-time diastolic, awake systolic and diastolic blood pressures, including comparison of % achieving target BP

Impact of individual medications on sleep-time blood pressure drop (dipping status)

Association of baseline renin levels to sleep-time blood pressure drop

Association of baseline renin levels with response to amlodipine versus lisinopril

Association of baseline dipping status with response to amlodipine versus lisinopril

Association of age and response to amlodipine versus lisinopril


Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Age 40 to 80

- Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor


- 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

Locations and Contacts

Additional Information

Starting date: April 2013
Last updated: April 18, 2013

Page last updated: August 23, 2015

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