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

NCT03635125 | Completed Phase 4 FDA Drug

• 1 other identifier: BYS-MD-48
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

JNC 7 Stage 1 or 2 Hypertension

Outcome Measures

Primary Outcomes (2)

• Mean Change from baseline in trough Diastolic Blood Pressure

  Mean change by millimeters of mercury from baseline in trough Diastolic Blood Pressure

  4 and 8 weeks of treatment

• Mean Change in Edema Measurement

  Mean change in edema measurement by water immersion of treatment in millimeters of water

  4 and 8 weeks of treatment

Secondary Outcomes (2)

• Change from baseline in trough Systolic blood pressure of treatment.

  4 and 8 weeks of treatment

• Percentage of subjects achieving Blood pressure goals

  4 and 8 weeks of treatment

Study Arms (4)

Background treatment phase

NO INTERVENTION

A 12- week Amlodipine 10 mg background treatment phase

Low Dose Treatment Phase-Nebivolol I

ACTIVE COMPARATOR

4-week low dose Nebivolol10 mg/Metoprolol 50 mg treatment phase

Drug: Nebivolol I; Drug: Nebivolol II

High dose treatment Phase-Nebivolol II

ACTIVE COMPARATOR

4-week High dose Nebivolol 20 mg/Metoprolol 100mg treatment phase

Drug: Nebivolol I; Drug: Nebivolol II

Baseline Washout Phase

OTHER

2 to 4 week Baseline Washout Phase

Other: Baseline Washout Phase

Interventions

Nebivolol I DRUG

Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg

Also known as: Metoprolol I

High dose treatment Phase-Nebivolol II; Low Dose Treatment Phase-Nebivolol I

Nebivolol II DRUG

Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg

Also known as: Metoprolol II

High dose treatment Phase-Nebivolol II; Low Dose Treatment Phase-Nebivolol I

Baseline Washout Phase OTHER

2 to 4 week Baseline Washout Phase

Baseline Washout Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trinity Hypertension & Metabolic Research Institute: lead

Study Sites (1)

Punzi Medical Center

Carrollton, Texas, 75006, United States

Location

Study Officials

• Henry A Punzi, MD

  Punzi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 15, 2018
• First Posted: August 17, 2018
• Study Start: August 30, 2010
• Primary Completion: May 26, 2011
• Study Completion: July 18, 2011
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)