Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

This study has been completed.

Sponsor:

Information provided by:

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00734630

First received: August 13, 2008

Last updated: March 31, 2011

Last verified: March 2011

History of Changes

Results First Received: March 31, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/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
Recruitment occured from August 2008 through November 2009 at 76 US sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Placebo washout phase was required for patients currently on anti-hypertensives at screening followed by a losartan or lisinopril run-in phase before assignment to Placebo or Nebivolol arms. Patients who were untreated at screening started the study at the open-label lead-in phase.

Reporting Groups

	Description
Nebivolol	Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
Placebo	Matching placebo tablets, oral administration

Participant Flow: Overall Study

	Nebivolol	Placebo
STARTED	258	233
COMPLETED	229	200
NOT COMPLETED	29	33
Lack of Efficacy	4	4
Withdrawal by Subject	7	9
Lost to Follow-up	13	7
Protocol Violation	0	3
Inclusion/Exclusion criteria not met	0	1
Adverse Event	3	6
Randomized in Error	0	1
Tested Positive for Illegal Drug Use	1	1
Poor Compliance	1	1

Baseline Characteristics

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Reporting Groups

	Description
Nebivolol	Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg 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]	258	233	491
Age [units: years] Mean ± Standard Deviation	52.1 ± 10.1	53.8 ± 9.6	52.9 ± 9.9
Age, Customized [units: Participants]
Between 18 and 65 Years	229	201	430
≥65 years	29	32	61
Gender [units: participants]
Female	104	92	196
Male	154	141	295
Region of Enrollment [units: participants]
United States	258	233	491

Outcome Measures

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1. Primary:

Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12 [ Time Frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12) ]

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2. Secondary:

Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12 [ Time Frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 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
No text entered.

Results Point of Contact:

Name/Title: Noah Rosenberg , MD, Exec. Dir, Clin Dev, Cardiovascular and Metabolism
Organization: Forest Laboratories, Inc.
phone: 2014278000 ext 2133
e-mail: noah.rosenberg@frx.com

No publications provided

Responsible Party:	Noah Rosenberg , MD, Exec. Dir, Clin Dev, Cardiovascular and Metabolism, Forest Research Institute, a Subsidairy of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00734630 History of Changes
Other Study ID Numbers:	NEB-MD-11
Study First Received:	August 13, 2008
Results First Received:	March 31, 2011
Last Updated:	March 31, 2011
Health Authority:	United States: Food and Drug Administration

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