Efficacy and Safety of Nebivolol (Added to Lisinopril or... | NCT00734630

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nebivolol	Active Comparator	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	Drug: nebivolol
Placebo	Placebo Comparator	Matching placebo tablets, oral administration	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nebivolol	Drug	Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12	Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).	From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

Secondary Outcomes

Measure	Description	Time Frame
Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12	Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).	From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Manfred Stapff, MD, PhD	Forest Research Institute, a subsidiary of Forest Laboratories, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Forest Investigative Site 070		Gulf Shores	Alabama	36535	United States
Forest Investigative Site 092

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23519546	Derived	Weiss RJ, Stapff M, Lin Y. Placebo effect and efficacy of nebivolol in patients with hypertension not controlled with lisinopril or losartan: a phase IV, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2013 Apr;13(2):129-40. doi: 10.1007/s40256-013-0010-y.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	Placebo	Matching placebo tablets, oral administration
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052.1± 10.1 BG00153.8± 9.6 BG00252.9± 9.9

Age, Customized

Number

Participants

Title

Denominators

Categories

Between 18 and 65 Years

Title	Measurements
	BG000229 BG001201 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000104 BG00192 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000258 BG001233 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12

Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).

Posted

Mean

Standard Deviation

mmHG

From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

ID	Title	Description
OG000	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
OG001	Placebo	Matching placebo tablets, oral administration

Units	Counts
Participants	OG000256 OG001232

Title

Denominators

Categories

Title	Measurements
	OG000-10.1± 16.9 OG001-7.3± 15.9

Secondary

Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12

Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).

Posted

Mean

Standard Deviation

mmHG

From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

ID	Title	Description
OG000	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
OG001	Placebo	Matching placebo tablets, oral administration

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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			1	258	0	258
EG001	Placebo	Matching placebo tablets, oral administration			3	233	0	233

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected258 at risk EG0011 affected233 at risk
Non-cardiac chest pain	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected258 at risk EG0011 affected233 at risk
Cellulitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 affected258 at risk EG0010 affected233 at risk
Acute pancreatitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 affected258 at risk EG0011 affected233 at risk
Anxiety	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0000 affected258 at risk EG0011 affected233 at risk

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D004151	Dipeptides
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases