- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03635125
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
40
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
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
|
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg
Other Names:
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg
Other Names:
|
Active Comparator: High dose treatment Phase-Nebivolol II
4-week High dose Nebivolol 20 mg/Metoprolol 100mg treatment phase
|
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg
Other Names:
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg
Other Names:
|
Other: Baseline Washout Phase
2 to 4 week Baseline Washout Phase
|
2 to 4 week Baseline Washout Phase
|
What is the study measuring?
Primary Outcome Measures
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
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.
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)
August 30, 2010
Primary Completion (Actual)
May 26, 2011
Study Completion (Actual)
July 18, 2011
Study Registration Dates
First Submitted
March 15, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
August 20, 2018
Last Update Submitted That Met QC Criteria
August 16, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Adrenergic beta-1 Receptor Agonists
- Nebivolol
- Metoprolol
Other Study ID 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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