Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life

NCT00999102 | Completed Phase 4 Results

• 1 other identifier: 0901010162
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is a recognized and common side effect of beta-blockers that can have significant effects on quality of life. Worse, many people taking a beta-blocker for years are not even aware of the reduction of energy with which they are living. A new vasodilating beta-blocker, nebivolol, which is approved by the FDA for treatment of hypertension, appears to be far less associated with fatigue than are most currently available beta-blockers. The purpose of this study is to compare nebivolol with the current best-selling beta-blocker, metoprolol, and determine whether there is a significant difference in side effects including fatigue, reduced exertion tolerance, and reduced quality of life. In this study, 30 subjects will take each of the 2 study drugs for 8 weeks, consisting of 4 weeks at a lower dose, and 4 weeks at a higher dose. All dosages are FDA-approved for treatment of hypertension. Subjects and investigators will not know which drug is being administered until completion of the study. Subjects will undergo a treadmill stress test and will complete fatigue and quality of life questionnaires after each 4 weeks of treatment. An echocardiogram and non-invasive measurement of aortic blood pressure will be performed after 8 weeks on each drug. Also, blood will be drawn and stored for possible measurement of drug levels, after 4 and 8 weeks on each drug. Results on each drug will then be compared. If nebivolol is found to cause significantly less fatigue, it would be of substantial importance to the many millions of people who are on life-long beta-blocker therapy, and are living with reduced energy.

Conditions

Hypertension

Keywords

hypertension; beta blockers; Metoprolol; blood pressure, high; antihypertensive agents; vascular resistance; adrenergic beta-receptor blockaders; beta-Adrenergic blockers; beta-Adrenergic Blocking Agents; beta-Adrenergic Receptor Blockaders; beta-Blockers, Adrenergic; Bystolic; Nebivolol; Nebivololum; Nebivololum [Latin]; R65,824; Beloc- Zok; H 93/26 succinate; Metoprolol succinate; Seloken ZOC; Selozok; Spesicor Dos; Toprol XL; Toprol-XL; UNII-TH25PD4CCB

Outcome Measures

Primary Outcomes (2)

• Multidimensional Assessment of Fatigue (MAF) Questionnaire: Global Fatigue Score After 4 Weeks of Treatment on Each Drug/Dose Combination.

  A 16 item scale that measures 4 dimensions of fatigue: severity, distress, timing, and degree of interference in activities of daily living. Range: 1 (no fatigue) to 50 (extreme fatigue).

  After 4 weeks of treatment on each drug/dose combination

• Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination.

  Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination (in minutes). The Treadmill Test was Performed at the 4-week Visit of Each Drug/Dose Combination.

  After 4 weeks of treatment on each drug/dose combination

Study Arms (2)

Nebivolol, followed by Metoprolol

EXPERIMENTAL

Participants first received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 9-16 in total).

Drug: Metoprolol; Drug: Nebivolol

Metoprolol, followed by Nebivolol

EXPERIMENTAL

Participants first received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 9-16 in total)

Drug: Metoprolol; Drug: Nebivolol

Interventions

Metoprolol DRUG

Metoprolol 50 mg, Metoprolol 100 mg,

Also known as: Lopressor, Toprol-XL

Metoprolol, followed by Nebivolol; Nebivolol, followed by Metoprolol

Nebivolol DRUG

Nebivolol 5 mg, Nebivolol 10 mg.

Also known as: Bystolic

Metoprolol, followed by Nebivolol; Nebivolol, followed by Metoprolol

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are taking, or are about to begin taking, a beta-blocker, and who have the approved indication of hypertension

You may not qualify if:

• Orthopedic ailments that would interfere with performance of treadmill testing
• Stroke or heart attack within the previous 1 year
• Symptomatic coronary disease within the past year (angina, shortness of breath)
• Clinically significant pulmonary disease (e.g. emphysema or asthma).
• Poorly controlled hypertension (blood pressure above 160 systolic or 100 diastolic)
• Patients with contra-indications to taking a beta-blocker (asthma or bradyarrhythmia)
• History of tachyarrhythmia (abnormal rapid heart rate)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Metoprolol; Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Ethanolamines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Samuel Mann, PI
• Organization: NY Presbyterian Hospital - Weill Cornell Medical Center

sjmann@med.cornell.edu

212-746-2200

Study Officials

• Samuel J Mann, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2009
• First Posted: October 21, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-10

Locations

US (1)