A Study of the Safety and Efficacy of Nebivolol in Hypert... | NCT00200473

Studies
A Study of the Safety and Efficacy of Nebivolol in Hypertensive Patients

NCT00200473

Sponsor

Mylan Bertek Pharmaceuticals

Status

Completed

Last Update Posted

Sep 20, 2005Estimated

Enrollment

800

Phase

Phase 3

Conditions

Hypertension

Interventions

Nebivolol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

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

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2001

Primary Completion Date

Not provided

Completion Date

Mar 2003

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2005

Last Update Posted Date

Sep 20, 2005Estimated

Description Module

Brief Summary

A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.

Detailed Description

This study was a multi-center, multi-national, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in and 2) randomization/double-blind treatment. Patients had 7 scheduled clinic visits during the study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800

Name	Type	Description	Arm Group Labels	Other Names
Nebivolol	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change of the average sitting diastolic blood pressure (24 plus/or minus 2 hours post-previous morning's dose) taken at trough at the end of the treatment compared to baseline

Secondary Outcomes

Measure	Description	Time Frame
- The change of the average sitting, supine and standing systolic and diastolic blood pressure at trough and peak at end of treatment compared to baseline
- Response rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline

Exclusion Criteria:

Recent myocardial infarction or stroke
Secondary hypertension
Contraindications to beta-blocker therapy or discontinuation of prior antihypertensive agents
Pregnancy, nursing or women of childbearing age not using appropriate contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Betty S. Riggs, MD, MBA	Mylan Pharmaceuticals Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mylan Pharmaceuticals Inc.		Morgantown	West Virginia	26505	United States

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068577	Nebivolol

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided