NCT00547300

Brief Summary

The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
49

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

24 active sites

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

First Submitted

Initial submission to the registry

October 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
9 days until next milestone

Study Start

First participant enrolled

October 31, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2008

Completed
11.4 years until next milestone

Results Posted

Study results publicly available

May 21, 2019

Completed
Last Updated

May 21, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

October 19, 2007

Results QC Date

October 19, 2010

Last Update Submit

April 30, 2019

Conditions

Hypertension

Keywords

HypertensionNebivololBeta blockerTolerability

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score

    The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).

    Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)

Secondary Outcomes (2)

  • Peripheral Blood Pressure (BP)

    Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)

  • Pulse Rate

    Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)

Study Arms (2)

Nebivolol

EXPERIMENTAL

Nebivolol 5 mg, 10 mg or 20 mg

Drug: Nebivolol

Metoprolol ER

ACTIVE COMPARATOR

Metoprolol ER 50 mg, 100 mg or 200 mg

Drug: Metoprolol ER

Interventions

Metoprolol ERDRUG

Metoprolol ER once daily, oral administration

Metoprolol ER
NebivololDRUG

Nebivolol once daily, oral administration

Nebivolol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, ambulatory outpatients
  • History of hypertension being treated with two medications, one of which must be HCTZ and the other of which must not be a beta-blocker or clonidine
  • SBP of 135-155 mm Hg and/or DBP of \>85 mm Hg at screening (Visit 1)
  • SBP of 140-165 mm Hg and DBP \> 90 mmHg at randomization (Visit 3)

You may not qualify if:

  • Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)
  • Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease)
  • Coronary artery disease requiring treatment with a calcium channel blocker or nitrates
  • Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)
  • History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1)
  • Use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants
  • Diabetes mellitus, type I or II
  • Participation in a previous investigational study of nebivolol at any time
  • Receipt of treatment with an investigational study drug within 30 days of screening (Visit 1)
  • History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Forest Research Institute 014

Birmingham, Alabama, 35205, United States

Location

Forest Research Institute 028

Beverly Hills, California, 90211, United States

Location

Forest Research Institute 054

Encinitas, California, 92024, United States

Location

Forest Research Institute 025

Roseville, California, 95661, United States

Location

Forest Research Institute 013

Tustin, California, 92780, United States

Location

Forest Research Institute 053

Vista, California, 92083, United States

Location

Forest Research Institute 052

Walnut Creek, California, 94598, United States

Location

Forest Research Institute 033

Westlake Village, California, 91361, United States

Location

Forest Research Institute 010

DeLand, Florida, 32720, United States

Location

Forest Research Institute 019

Holly Hill, Florida, 32117, United States

Location

Forest Research Institute 036

Hollywood, Florida, 33023, United States

Location

Forest Research Institute 007

Pembroke Pines, Florida, 33024, United States

Location

Forest Research Institute 009

Atlanta, Georgia, 30338, United States

Location

Forest Research Institute 006

Oxon Hill, Maryland, 20745, United States

Location

Forest Research Institute 027

Las Vegas, Nevada, 89106, United States

Location

Forest Research Institute 050

Salisbury, North Carolina, 28144, United States

Location

Forest Research Institute 039

Wilmington, North Carolina, 28401, United States

Location

Forest Investigative Site 002

Charleston, South Carolina, 29407, United States

Location

Forest Research Institute 032

Greenville, South Carolina, 29615, United States

Location

Forest Research Institute 008

Nashville, Tennessee, 37203, United States

Location

Forest Research Institute 003

Carrollton, Texas, 75006, United States

Location

Forest Research Institute 012

San Antonio, Texas, 78229, United States

Location

Forest Research Institute 048

Sugar Land, Texas, 77479, United States

Location

Forest Research Institute 040

Bountiful, Utah, 84010, United States

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

MetoprololNebivolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesEthanolaminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

Study was terminated early due to administrative reasons. Formal analyses of primary and secondary endpoints were not conducted in this study.

Results Point of Contact

Title
Therapeutic Area Head
Organization
Allergan
clinicaltrials@allergan.com
714-246-4500

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 22, 2007

Study Start

October 31, 2007

Primary Completion

January 2, 2008

Study Completion

January 2, 2008

Last Updated

May 21, 2019

Results First Posted

May 21, 2019

Record last verified: 2019-04

Locations

US(24)