A Study on the Efficacy and Safety of Nebivolol Monothera... | NCT00770861

NCT00770861

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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 Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol 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	Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Trough Seated DBP at Week 8(LOCF).	The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.	From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).	The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.	From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Tatjana Lukic, MD., M.Sc.	Forest Research Institute, a subsidiary of Forest Laboratories Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Forest Investigative Site		Buena Park	California	90620	United States
Forest Investigative Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nebivolol	Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Nebivolol	Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol 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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00050.4± 8.7 BG00150.4± 8.7 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00062 BG00151 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000134 BG001131 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

Change From Baseline in Trough Seated DBP at Week 8(LOCF).

The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.

Posted

Mean

Standard Deviation

mm Hg

From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

ID	Title	Description
OG000	Nebivolol	Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
OG001	Placebo	Matching placebo tablets, oral administration

Units	Counts
Participants	OG000141 OG001135

Title

Denominators

Categories

Title	Measurements
	OG000-11.1± 8.8 OG001-7.3± 8.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	H0 - There was no difference in BP reduction between Neb and Placebo. The efficacy analyses were based on the ITT population for the double-blind treatment phase. The LOCF was used to impute missing postbaseline values. Sensitivity analyses were based on observed cases for all efficacy parameters. All statistical tests were two-sided hypothesis tests performed at the 5% level of significance for main effects. All confidence intervals were two-sided 95% confidence intervals.	ANCOVA	Between-treatment comparison of efficacy was performed by ANCOVA, with treatment, baseline BMI, center as factors & baseline value as a covariate.	<0.0001							95						No

Secondary

Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).

The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.

Posted

Mean

Standard Deviation

mm Hg

From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

ID	Title	Description
OG000	Nebivolol	Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol 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 Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration			0	141	5	141
EG001	Placebo	Matching placebo tablets, oral administration			1	136	8	136

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Alanine aminotransferase increased	Investigations	MedDRA 12.0	Systematic Assessment		EG0000 affected141 at risk EG0011 affected136 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 12.0	Systematic Assessment		EG0000 affected141 at risk EG0011 affected136 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment		EG0005 affected141 at risk EG0018 affected136 at risk

ID	Term
D006973	Hypertension

ID	Term
D000068577	Nebivolol

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

Superiority or Other

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases