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

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ClinicalTrials.gov Identifier: NCT01057251
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : January 11, 2012
Last Update Posted : January 11, 2012
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : March 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057251


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01057251     History of Changes
Other Study ID Numbers: NEB-MD-20
First Posted: January 27, 2010    Key Record Dates
Results First Posted: January 11, 2012
Last Update Posted: January 11, 2012
Last Verified: December 2011

Keywords provided by Forest Laboratories:
Nebivolol
Bystolic TM
Hypertension
Stage 2 Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nebivolol
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