NCT01679652

Brief Summary

Investigators want investigate the following hypothesis:

  1. 1.Nebivolol increases nitric oxide activity in the systemic circulation and the kidney
  2. 2.The increased activity of nitric oxide during nebivolol treatment can be demonstrated by inhibition of NO synthesis with L-NMMA. We expect increased responses in blood pressure and sodium excretion is expected during nebivolol treatment compared to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

1.1 years

First QC Date

September 1, 2012

Last Update Submit

March 1, 2014

Conditions

Essential Hypertension

Keywords

Essential hypertensionNitric oxideNebivololFractional excretion of sodium

Outcome Measures

Primary Outcomes (1)

  • Fractional excretion of sodium

    5 days

Secondary Outcomes (14)

  • Blood pressure

    5 days

  • Pulse wave velocity

    5 days

  • Plasma renin concentration

    5 days

  • Plasma aldosterone concentration

    5 days

  • Plasma angiotensin II concentration

    5 days

  • +9 more secondary outcomes

Study Arms (2)

Nebivolol

EXPERIMENTAL

Tablet Nebivolol 5 mg (oral use) for 5 days

Drug: Nebivolol

Placebo

PLACEBO COMPARATOR

Inactive placebo given as tablet for 5 days

Drug: placebo

Interventions

NebivololDRUG

Tablet i blinded in capsula

Also known as: Tradename in Denmark: Hypoloc
Nebivolol
placeboDRUG
Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Increased blood pressure (above 135 mmHg systolic or 85 mmHg diastolic in day time in 24 hour blood pressure measurement taking 5 or 10 mg amlodipine
  • Men and women
  • age 40 - 70 years
  • informed consent

You may not qualify if:

  • diabetes mellitus
  • glomerular filtration rate \< 30 ml/min
  • albuminuria \> 1,5 g/l
  • renogram which suggests secondary hypertension
  • clinical signs of pheochromocytoma or increased p-metanephrines
  • clinical important sign og heart, lung, liver, thyroid or neoplastic diseases
  • clinical important deviations in routine blood samples or ECG
  • drug or alcohol abuse
  • pregnancy or nursery
  • intolerance to nebivolol
  • blood donation with a month of the first examination day
  • inacceptable increase in blood pressure durin L-NMMA infusion (200/120)
  • inacceptable side effects to amlodipine
  • blood pressure increase above 170/105 on highest dose amlodipine (10 mg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Erling B Pedersen, MD

    Department of medical Research, Holstebro Hospital

    STUDY CHAIR

  • Frank H Mose, MD

    Department of Medical Research, Holstebro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 1, 2012

First Posted

September 6, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

DK(1)