A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients

This study has been completed.

Sponsor:

Information provided by:

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00648895

First received: March 28, 2008

Last updated: August 30, 2010

Last verified: August 2010

History of Changes

Results First Received: July 21, 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: Metoprolol ER (TM)

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 from November 2007 to May 2009 at one US location.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients went through a 4-5 week, single blind, placebo washout phase before randomization.

Reporting Groups

	Description
Nebivolol	A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
Metoprolol ER (TM)	A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.

Participant Flow: Overall Study

	Nebivolol	Metoprolol ER (TM)
STARTED	6	6
COMPLETED	6	5
NOT COMPLETED	0	1
Lack of Efficacy	0	1

Baseline Characteristics

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Reporting Groups

	Description
Nebivolol	A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
Metoprolol ER (TM)	A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
Total	Total of all reporting groups

Baseline Measures

	Nebivolol	Metoprolol ER (TM)	Total
Number of Participants [units: participants]	6	6	12
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	4	1	5
>=65 years	2	5	7
Age [units: years] Mean ± Standard Deviation	59.5 ± 5.8	67.3 ± 11.6	63.4 ± 9.7
Gender [units: participants]
Female	2	0	2
Male	4	6	10
Region of Enrollment [units: participants]
United States	6	6	12

Outcome Measures

1. Primary:

Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR). [ Time Frame: Before treatment and after 10 weeks ]

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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 12 of 30 planned patients were enrolled.

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:	NCT00648895 History of Changes
Other Study ID Numbers:	NEB-MD-08
Study First Received:	March 28, 2008
Results First Received:	July 21, 2010
Last Updated:	August 30, 2010
Health Authority:	United States: Food and Drug Administration

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