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Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

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ClinicalTrials.gov Identifier: NCT01415531
Recruitment Status : Completed
First Posted : August 12, 2011
Results First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 641 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension
Study Start Date : August 2011
Primary Completion Date : March 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Drug: Nebivolol
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Placebo Comparator: 2
Dose-matched placebo
Drug: Placebo
Dose-match placebo


Outcome Measures

Primary Outcome Measures :
  1. Trough Seated Diastolic Blood Pressure (DBP) [ Time Frame: Change from Baseline to Week 8 ]
    Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.


Secondary Outcome Measures :
  1. Trough Seated Systolic Blood Pressure (SBP) [ Time Frame: Change from Baseline to Week 8 ]
    Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female outpatients, of age 18 - 54 years
  • Patients diagnosed with stage 1 or stage 2 essential hypertension
  • Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

  • Secondary hypertension or severe hypertension
  • History of Type 1 diabetes mellitus
  • A medical contraindication to discontinuing a current antihypertensive therapy
  • Clinically significant respiratory disease that prohibit use of a beta blocker
Contacts and Locations

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): NCT01415531


  Show 75 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Tatjana Lukic, MD, M. Sc. Forest Laboratories
More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01415531     History of Changes
Other Study ID Numbers: NEB-MD-28
First Posted: August 12, 2011    Key Record Dates
Results First Posted: May 16, 2013
Last Update Posted: May 16, 2013
Last Verified: March 2013

Keywords provided by Forest Laboratories:
Stage 1
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