Efficacy and Safety of Nebivolol Versus Metoprolol in Hypertensive Subject Taking Amlodipine

August 16, 2018 updated by: Trinity Hypertension & Metabolic Research Institute

A Prospective, Randomized, Open-Label, Active-Comparator, Blinded-Endpoint, 12-week Forced-Titration Study of the Efficacy and Safety of Nebivolol Verses Metoprolol in Hypertensive Subjects Taking Amlodipine

Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Open-label, single center study consisting of a 2 to 4 week baseline washout phase, a 12-week Amlodipine background treatment phase followed by a 4-week Low Dose Nebivolol/Metoprolol Treatment phase and a 4-week High Dose Nebivolol/Metoprolol Treatment Phase.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Carrollton, Texas, United States, 75006
        • Punzi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Capable of reading, comprehending the consent process and providing written informed consent to participate in the study.
  • Male or female equal/over 18 years of age.
  • Stage I-II hypertension defined as a baseline mean seated cuff Diastolic blood pressure of equal/over 95 mmHg and equal/less 115 mmHg and Systolic blood pressure equal/less to 180 mmHg at two consecutive qualifying visits during the placebo run in period.
  • Arm circumference less 45 cm
  • Compliance with single blind placebo capsules between V1-4 of 80-120%.
  • Women may be enrolled if all three of the following criteria are met:
  • Have a negative serum pregnancy test at screening
  • Are not breastfeeding
  • Do not plan to become pregnant during the study and if one of the three criteria is met:
  • Have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form
  • Have been postmenopausal for at least 1 year
  • Are of childbearing potential and will practice one the following methods of birth control throughout the study: oral, patch, injectable, or implantable hormone contraception, intrauterine device, diaphragm plus spermicide or female condom plus spermicide. Abstinence, partner's vasectomy are not acceptable methods of contraception.

Exclusion Criteria:

  • Known allergy or hypersensitivity to Beta Blockers.
  • Known allergy or hypersensitivity to Calcium Channel Blockers.
  • Patients with severe hypertension (mean seated cuff Diastolic blood pressure > 115 mmHg or mean seated Systolic blood pressure >180 mmHg) or any form of secondary hypertension.
  • Patients within the past 6 months with a history of hypertensive encephalopathy, stroke or transient ischemic attack.
  • Patients within the last 6 months with a history of myocardial infarction, percutaneous trans luminal coronary revascularization, coronary bypass graft, valvular surgery or unstable angina.
  • Patients with evidence of resting bradycardia (<50 bpm) via palpation.
  • Patients with a history of heart block greater than First Degree Sino atrial Block. Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial Fibrillation, Atrial Flutter, Congestive Heart Failure, or other manifestations of clinically significant cardiac valvular disease.
  • Patients with hemodynamically significant cardiac valvular disease.
  • Patients with evidence of significant chronic renal impairment as indicated by a serum creatinine of > 2.5mg/dL
  • Patients with evidence of liver disease as indicated by AST (SGOT) or ALT (SGPT) > 2.5 times or total bilirubin > 1.5 times, the upper limit of the laboratory normal range.
  • Patients who demonstrate other laboratory test values deviating from the Normal range which are considered to be clinically significant by the investigator.
  • Patient with a history or presence of gastrointestinal disease which may interfere with drug absorption.
  • Patients with insulin and non-insulin dependent diabetes mellitus not controlled on diet, insulin or oral hypoglycemic as defined by a HgA1c >10.
  • Severe psychological or emotional condition which may interfere with participation in the study.
  • History of or current use of illicit drugs or alcohol abuse.
  • Participation in a clinical trial and taking any investigation drug within 30 days prior to enrolling into the study (Screening Visit).
  • A physical condition that would limit accurate BP measurement.
  • Inability to swallow a tablet or capsule.
  • History of moderate or sever asthma or Chronic obstructive pulmonary disease.
  • Any other medical condition which, in the Investigator's opinion, may render the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Background treatment phase
A 12- week Amlodipine 10 mg background treatment phase
Active Comparator: Low Dose Treatment Phase-Nebivolol I
4-week low dose Nebivolol10 mg/Metoprolol 50 mg treatment phase
Drug: Nebivolol I
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg
Other Names:
  • Metoprolol I
Drug: Nebivolol II
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg
Other Names:
  • Metoprolol II
Active Comparator: High dose treatment Phase-Nebivolol II
4-week High dose Nebivolol 20 mg/Metoprolol 100mg treatment phase
Drug: Nebivolol I
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg
Other Names:
  • Metoprolol I
Drug: Nebivolol II
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg
Other Names:
  • Metoprolol II
Other: Baseline Washout Phase
2 to 4 week Baseline Washout Phase
Other: Baseline Washout Phase
2 to 4 week Baseline Washout Phase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change from baseline in trough Diastolic Blood Pressure
Time Frame: 4 and 8 weeks of treatment
Mean change by millimeters of mercury from baseline in trough Diastolic Blood Pressure
4 and 8 weeks of treatment
Mean Change in Edema Measurement
Time Frame: 4 and 8 weeks of treatment
Mean change in edema measurement by water immersion of treatment in millimeters of water
4 and 8 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in trough Systolic blood pressure of treatment.
Time Frame: 4 and 8 weeks of treatment
Change from baseline by millimeters of mercury in trough Systolic blood pressure of treatment.
4 and 8 weeks of treatment
Percentage of subjects achieving Blood pressure goals
Time Frame: 4 and 8 weeks of treatment
Percentage of subjects achieving Blood pressure goals of either Nebivolol compared to Metoprolol
4 and 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trinity Hypertension & Metabolic Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BYS-MD-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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