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Nebivolol in Patients With Systolic Stage 2 Hypertension (NEB-MD-20)

This study has been completed.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: January 26, 2010
Last updated: December 6, 2011
Last verified: December 2011
The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Condition Intervention Phase
Drug: Nebivolol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy [ Time Frame: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6) ]
    Office blood pressure measured at trough by automatic oscillometric device.

  • Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy [ Time Frame: Change from Baseline (Week 0) to Visit 4 (Week 6) ]
    Office blood pressure measured at trough by automatic oscillometric device.

Enrollment: 433
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Nebivolol
5 mg, titrated to 20 mg, once daily oral administration
Other Name: Bystolic
Placebo Comparator: 2 Drug: Placebo
5 mg or 20 mg once daily, oral administration


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male of female, 18 to 64 years of age at screening
  • mean seated heart rate at least 60 bpm
  • diagnosed systolic stage 2 hypertension
  • unremarkable physical exam findings

Exclusion Criteria:

  • high risk due to secondary hypertension or former stage 3 hypertension by JNC6
  • concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
  • currently taking medication that cannot be stopped during the course of the study
  • participating other clinical trials
  • member of the study center personnel
  • documented drug abuse
  • contra indication to beta blocker
  • abnormal lab finding
  • poor compliance
  • other conditions judged by investigator that is not suitable for the study
  Contacts and Locations
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Please refer to this study by its identifier: NCT01057251

  Show 36 Study Locations
Sponsors and Collaborators
Forest Laboratories
Study Director: Manfred Stapff, MD, PhD Forest Research Institute, a Subsidiary of Forest Laboratories Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Forest Laboratories Identifier: NCT01057251     History of Changes
Other Study ID Numbers: NEB-MD-20
Study First Received: January 26, 2010
Results First Received: December 6, 2011
Last Updated: December 6, 2011

Keywords provided by Forest Laboratories:
Bystolic TM
Stage 2 Hypertension

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 24, 2017