A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

This study has been completed.

Sponsor:

Information provided by:

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00785512

First received: November 3, 2008

Last updated: August 19, 2010

Last verified: August 2010

History of Changes

Results First Received: August 19, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); 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
The recruitment period was five months, from November 2008 through March 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients went through a 4-5 week, single blind, placebo run-in/washout phase, followed by a 12 week single-blind active treatment phase with nebivolol before randomization

Reporting Groups

	Description
Nebivolol	Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
Placebo	Matching placebo tablets, oral administration

Participant Flow: Overall Study

	Nebivolol	Placebo
STARTED	102	105
COMPLETED	99	101
NOT COMPLETED	3	4
Inclusion/Exclusion not meet	0	0
Adverse Event	0	0
Lack of Efficacy	0	2
Withdrawal by Subject	0	1
Lost to Follow-up	3	0
Precedure Refused	0	0
IVRS Programing Error	0	0
Physician Decision	0	0
Lack of compliance	0	1

Baseline Characteristics

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Reporting Groups

	Description
Nebivolol	Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
Placebo	Matching placebo tablets, oral administration
Total	Total of all reporting groups

Baseline Measures

	Nebivolol	Placebo	Total
Number of Participants [units: participants]	102	105	207
Age [units: participants]
<18 years	0	0	0
Ages 18 to 64 years	86	91	177
>=65 years	16	14	30
Age [units: years] Mean ± Standard Deviation	52.6 ± 11.2	52.9 ± 10.2	52.8 ± 10.6
Gender [units: participants]
Female	43	43	86
Male	59	62	121
Region of Enrollment [units: participants]
United States	102	105	207

Outcome Measures

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1. Primary:

Trough Sitting Diastolic Blood Pressure [ Time Frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12) ]

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Measure Type	Primary
Measure Title	Trough Sitting Diastolic Blood Pressure
Measure Description	Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.
Time Frame	From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Nebivolol	Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
Placebo	Matching placebo tablets, oral administration

Measured Values

	Nebivolol	Placebo
Number of Participants Analyzed [units: participants]	101	105
Trough Sitting Diastolic Blood Pressure [units: mm HG] Mean ± Standard Deviation
Baseline	81.3 ± 7.2	81.1 ± 7.0
Change from baseline	1.8 ± 7.3	7.7 ± 8.6

No statistical analysis provided for Trough Sitting Diastolic Blood Pressure

2. Secondary:

Trough Sitting Systolic Blood Pressure [ Time Frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12) ]

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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: Sponsor can review results communications prior to public release & can embargo communications re: results for 60 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential information. Upon sponsor's request, PI shall delete any proprietary info & shall not include raw data in the publication. On sponsor's request, PI shall delay submission for any pub while sponsor files patent applications. Any publication will give recognition to Sponsor's support.

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
None

Results Point of Contact:

Name/Title: John Whalen, MD Executive Director of Clinical Development - Cardiovascular and Metabolism
Organization: Forest Laboratories
phone: 1-201-427-8259
e-mail: John.Whalen@frx.com

No publications provided

Responsible Party:	John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc
ClinicalTrials.gov Identifier:	NCT00785512 History of Changes
Other Study ID Numbers:	NEB-MD-17
Study First Received:	November 3, 2008
Results First Received:	August 19, 2010
Last Updated:	August 19, 2010
Health Authority:	United States: Food and Drug Administration

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