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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01415531
First received: August 10, 2011
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Hypertension
Drug: Nebivolol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Trough Seated Diastolic Blood Pressure (DBP) [ Time Frame: Change from Baseline to Week 8 ] [ Designated as safety issue: No ]
    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:
  • Trough Seated Systolic Blood Pressure (SBP) [ Time Frame: Change from Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 641
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
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
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: NCT01415531

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

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01415531     History of Changes
Other Study ID Numbers: NEB-MD-28
Study First Received: August 10, 2011
Results First Received: March 18, 2013
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Stage 1
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 August 01, 2014