Bedtime Administration of Amlodipine Versus Lisinopril

Not Applicable

• Conditions: Hypertension
• Interventions: Drug: Amlodipine

• Registration Number: NCT01835418
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-21
• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-18
• Last Update Submitted: 2013-04-18
• Study First Posted: 2013-04-19
• Last Update Posted: 2013-04-19
• Primary Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lisinopril	Amlodipine	bedtime administration of lisinopril 20mg
Amlodipine	Amlodipine	Bedtime administration of amlodipine 5mg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in mean sleep-time diastolic, awake systolic and diastolic blood pressures, including comparison of % achieving target BP	1 year
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
Association of baseline renin levels with response to amlodipine versus lisinopril	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