Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT01218100

First received: October 7, 2010

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: May 18, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Stage 2 Diastolic Hypertension
Interventions:	Drug: nebivolol and lisinopril (free combination) Drug: nebivolol monotherapy Drug: lisinopril monotherapy 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
664 patients were randomized to receive double-blind treatment; 661 patients received at least 1 dose of double-blind treatment (Safety Population); and 656 patients had at least 1 postbaseline assessment of trough seated DBP (ITT Population)

Reporting Groups

	Description
Placebo	Placebo group - starting dose is placebo
Nebivolol + Lisinopril (Combination)	Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
Nebivolol	Nebivolol monotherapy group - starting dose level nebivolol 5mg
Lisinopril	Lisinopril monotherapy group - starting dose level lisinopril 10mg

Participant Flow: Overall Study

	Placebo	Nebivolol + Lisinopril (Combination)	Nebivolol	Lisinopril
STARTED	95	190	189	190
COMPLETED	71	165	162	156
NOT COMPLETED	24	25	27	34
Did not meet InclusionExclusion criteria	1	1	1	2
Adverse Event	4	6	6	7
Lack of Efficacy	9	6	5	12
Protocol Violation	0	0	1	1
Withdrawal by Subject	5	2	6	7
Lost to Follow-up	3	8	2	1
Other Reason	2	2	6	4

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo group - starting dose is placebo
Nebivolol + Lisinopril (Combination)	Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
Nebivolol	Nebivolol monotherapy group - starting dose level nebivolol 5mg
Lisinopril	Lisinopril monotherapy group - starting dose level lisinopril 10mg
Total	Total of all reporting groups

Baseline Measures

	Placebo	Nebivolol + Lisinopril (Combination)	Nebivolol	Lisinopril	Total
Number of Participants [units: participants]	95	189	188	189	661
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	95	189	188	189	661
>=65 years	0	0	0	0	0
Age [units: years] Mean ± Standard Deviation	47.4 ± 9.7	48.8 ± 8.4	49.7 ± 8.4	50.1 ± 8	49.2 ± 8.5
Gender [units: participants]
Female	47	75	82	74	278
Male	48	114	106	115	383
Region of Enrollment [units: participants]
United States	95	189	188	189	661

Outcome Measures

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1. Primary:

The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6. [ Time Frame: Visit 6/(Week 0) and Visit 9/(Week 6) ]

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2. Secondary:

The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6. [ Time Frame: Visit 6/(Week 0) and Visit 9/(Week 6) ]

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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: Manfred Stapff, MD, PhD
Organization: Forest Research Institute
phone: 201-427-8000
e-mail: Manfred.stapff@frx.com

No publications provided

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT01218100 History of Changes
Other Study ID Numbers:	NEB-MD-25
Study First Received:	October 7, 2010
Results First Received:	May 18, 2012
Last Updated:	May 18, 2012
Health Authority:	United States: Food and Drug Administration

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