NCT00825123

Brief Summary

The purpose of this project is to determine the effects of slowing heart rate upon both central and peripheral blood pressures using Ivabradine. The effects of Ivabradine will be compared to Metoprolol and placebo. Participants will attend the hospital for 3 visits where they will be randomised to receive either Ivabradine, Metoprolol and placebo on each visit. Non-invasive measures of blood pressure will be recorded before and after consuming the study drug.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2011

Completed
Last Updated

August 17, 2020

Status Verified

November 1, 2009

Enrollment Period

3.1 years

First QC Date

January 15, 2009

Last Update Submit

August 13, 2020

Conditions

Central Arterial Pressure

Keywords

healthy individuals

Outcome Measures

Primary Outcomes (1)

  • central arterial pressure

    baseline and 4 hours post treatment

Study Arms (3)

Ivabradine

EXPERIMENTAL
Drug: Ivabradine

Metoprolol

ACTIVE COMPARATOR
Drug: Metoprolol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IvabradineDRUG

Ivabradine 10 mg once

Also known as: Coralan
Ivabradine
MetoprololDRUG

Metoprolol 50 mg once

Metoprolol
PlaceboDRUG

Lactose powder

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers:
  • aged 18 - 25 years OR
  • aged \>60 years

You may not qualify if:

  • Chronic disease
  • Unable to give informed consent
  • Treated or untreated systemic arterial hypertension (SBP \>160mmHg and/or DBP \> 90mmHg)
  • Resting bradycardia (heart rate \< 60 beats/minute)
  • Pregnancy or active lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Interventions

IvabradineMetoprolol

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Bronwyn A Kingwell, PhD

    Baker IDI Hearte & Diabetes Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 19, 2009

Study Start

October 1, 2008

Primary Completion

November 8, 2011

Study Completion

November 8, 2011

Last Updated

August 17, 2020

Record last verified: 2009-11

Locations

AU(1)