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
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.
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 BPImpact 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
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: April 2013
Last updated: April 18, 2013
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