NCT00125853

Brief Summary

The purpose of this study is to conduct a randomised trial to compare the insulin sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable hypertension

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

First Submitted

Initial submission to the registry

July 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
11 years until next milestone

Results Posted

Study results publicly available

December 12, 2019

Completed
Last Updated

December 12, 2019

Status Verified

November 1, 2019

Enrollment Period

2.5 years

First QC Date

July 29, 2005

Results QC Date

June 12, 2019

Last Update Submit

November 21, 2019

Conditions

Hypertension

Keywords

blood pressureinsulin sensitivitybeta blockersrandomised double blind crossover trial

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity Index (ISI)

    Patients were asked to fast for a minimum of 12 hours prior to each oral glucose tolerance test (OGTT). Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load. For each OGTT, the Insulin Sensitivity Index (ISI) was calculated using the standard method for oral glucose tolerance testing. For each OGTT, the Insulin Sensitivity Index (ISI) was calculated using the standard method for oral glucose tolerance testing.

    Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment

Secondary Outcomes (4)

  • 24 Hour Systolic Blood Pressure

    Before and after 8 weeks of treatment

  • Total Cholesterol

    Before and after 8 weeks of treatment

  • HbA1c

    Before and after 8 weeks of treatment

  • BMI

    Before and after 8 weeks of treatment

Study Arms (2)

atenolol 25mg daily

EXPERIMENTAL

atenolol 25mg daily

Drug: Atenolol

nebivolol 2.5mg daily

ACTIVE COMPARATOR

nebivolol 2.5mg daily

Drug: Nebivolol

Interventions

NebivololDRUG

Nebivolol 2.5mg daily

nebivolol 2.5mg daily
AtenololDRUG

Atenolol 25mg daily

atenolol 25mg daily

Eligibility Criteria

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

You may qualify if:

  • Males or females aged 18 or above
  • Blood pressure that meets any of the three following criteria:
  • BP should be \<140/85 mmHg on a maximum of two anti-hypertensive drugs

You may not qualify if:

  • contraindications to beta-blockade
  • contraindications to thiazide use
  • if there was a history of asthma, diabetes, heart failure, bradycardia, atrial fibrillation, AV conduction disturbances
  • concurrent treatment with verapamil \& dilitiazem
  • childbearing women
  • compelling indication for treatment with a beta blocker
  • any condition that will interfere with the treatment or the patient's ability to complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

Paddington, London, W2 1PG, United Kingdom

Location

MeSH Terms

Conditions

HypertensionInsulin Resistance

Interventions

NebivololAtenolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Professor Neil Poulter
Organization
Imperial College London
n.poulter@imperial.ac.uk
+44 2075943445

Study Officials

  • Neil R Poulter

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 2, 2005

Study Start

July 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 12, 2019

Results First Posted

December 12, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)