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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01057251
First received: January 26, 2010
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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
Hypertension
Drug: Nebivolol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided by Forest Laboratories

Additional 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
Study First Received: January 26, 2010
Results First Received: December 6, 2011
Last Updated: December 6, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nebivolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014