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

Results First Received: March 18, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Nebivolol Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient recruitment occurred over a 4 month period from August 2011 to December 2011 at 76 study sites in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Dose-matched placebo
Nebivolol	Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration

Participant Flow: Overall Study

	Placebo	Nebivolol
STARTED	214	427
COMPLETED	189	390
NOT COMPLETED	25	37
Adverse Event	7	10
Lack of Efficacy	3	2
Protocol Violation	0	1
Withdrawal by Subject	5	4
Lost to Follow-up	6	14
Lack of Compliance	1	4
Other Reasons	3	2

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Dose-matched placebo
Nebivolol	Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Total	Total of all reporting groups

Baseline Measures

	Placebo	Nebivolol	Total
Number of Participants [units: participants]	214	427	641
Age [units: years] Mean ± Standard Deviation
18 to 54	46.0 ± 6.9	44.9 ± 6.9	45.3 ± 6.9
Gender [units: participants]
Female	95	190	285
Male	119	237	356
Region of Enrollment [units: participants]
United States	214	427	641

Outcome Measures

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1. Primary:

Trough Seated Diastolic Blood Pressure (DBP) [ Time Frame: Change from Baseline to Week 8 ]

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2. Secondary:

Trough Seated Systolic Blood Pressure (SBP) [ Time Frame: Change from Baseline to Week 8 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Tatjana Lukic, MD, MSc
Organization: Forest Research Institute
phone: (201) 427-8649
e-mail: tanya.lukic@frx.com

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

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