NCT01835418

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hypertension

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

1.2 years

First QC Date

February 21, 2013

Last Update Submit

April 18, 2013

Conditions

Hypertension

Keywords

managed with bedtime administration of lisinopril versus amlodipine

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Lisinopril

EXPERIMENTAL

bedtime administration of lisinopril 20mg

Drug: Amlodipine

Amlodipine

EXPERIMENTAL

Bedtime administration of amlodipine 5mg

Drug: Amlodipine

Interventions

AmlodipineDRUG

crossover comparison of amlodipine vs lisinopril

AmlodipineLisinopril

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 to 80
  • Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor criteria.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

February 21, 2013

First Posted

April 19, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Last Updated

April 19, 2013

Record last verified: 2013-04