The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

This study has been completed.

Study NCT00673075 Information provided by Forest Laboratories

First Received on April 29, 2008. Last Updated on September 2, 2010 History of Changes

Results First Received: September 2, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Hypertension Coronary Artery Disease
Interventions:	Drug: Nebivolol Drug: Carvedilol

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 April 2008 to May 2009 at 35 US locations.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients went through a 4-week, single blind, metoprolol run-in phase before randomization.

Reporting Groups

	Description
Nebivolol	Encapsulated Nebivolol
Carvedilol	Encapsulated Carvedilol

Participant Flow: Overall Study

	Nebivolol	Carvedilol
STARTED	21	18
COMPLETED	12	11
NOT COMPLETED	9	7

Baseline Characteristics

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Reporting Groups

	Description
Nebivolol	Encapsulated Nebivolol
Carvedilol	Encapsulated Carvedilol

Baseline Measures

	Nebivolol	Carvedilol	Total
Number of Participants [units: participants]	21	18	39
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	12	9	21
>=65 years	9	9	18
Age [units: years] Mean ± Standard Deviation	60.6 ± 10.5	66.6 ± 10.3	63.4 ± 10.7
Gender [units: participants]
Female	1	6	7
Male	20	12	32
Region of Enrollment [units: participants]
United States	21	18	39

Outcome Measures

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1. Primary:

Peripheral Diastolic Blood Pressure (DBP) [ Time Frame: 18 weeks post initiation of randomized treatment ]

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2. Secondary:

Peripheral Systolic Blood Pressure (SBP) [ Time Frame: 18 weeks post initiation of randomized treatment ]

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3. Secondary:

Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18 [ Time Frame: 18 weeks post-treatment ]

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4. Secondary:

Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 [ Time Frame: 18 weeks post-treatment ]

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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
The study was terminated early because of difficulties with enrollment. Only 39 out of 160 planned patients were randomized.

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:	NCT00673075 History of Changes
Other Study ID Numbers:	NEB-MD-06
Study First Received:	April 29, 2008
Results First Received:	September 2, 2010
Last Updated:	September 2, 2010
Health Authority:	United States: Food and Drug Administration