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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
History of Changes

August 10, 2011
March 18, 2013
August 2011
March 2012   (final data collection date for primary outcome measure)
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.
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
Complete list of historical versions of study NCT01415531 on ClinicalTrials.gov Archive Site
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.
  • Systolic Blood Pressure (SBP) [ Time Frame: Change from Baseline at Week 8 ] [ Designated as safety issue: Yes ]
    Change from baseline in mean seated trough cuff systolic blood pressure (SBP) at Week 8 as measured by an Omron device
  • Adverse Event Recording [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Drug: Nebivolol
    Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
  • Drug: Placebo
    Dose-match placebo
  • Experimental: 1
    Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
    Intervention: Drug: Nebivolol
  • Placebo Comparator: 2
    Dose-matched placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
641
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 54 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01415531
NEB-MD-28
No
Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Tatjana Lukic, MD, M. Sc. Forest Laboratories
Forest Laboratories
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP