Bedtime Administration of Amlodipine Versus Lisinopril

NCT ID: NCT01835418

Last Updated: 2013-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lisinopril

bedtime administration of lisinopril 20mg

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

crossover comparison of amlodipine vs lisinopril

Amlodipine

Bedtime administration of amlodipine 5mg

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

crossover comparison of amlodipine vs lisinopril

Interventions

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Amlodipine

crossover comparison of amlodipine vs lisinopril

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allina Health System

OTHER

Sponsor Role lead

Responsible Party

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David Ingham

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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9529148100

Identifier Type: -

Identifier Source: org_study_id

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