Factorial Study of Metoprolol Succinate TOPROL-XL (324A) | NCT00642096

Studies
Factorial Study of Metoprolol Succinate TOPROL-XL (324A)

NCT00642096

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 25, 2009Estimated

Enrollment

1,900Estimated

Phase

Phase 3

Conditions

High Blood Pressure (Hypertension).

Interventions

Metoprolol Succinate
Hydrochlorothiazide

Countries

Not provided

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

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Jul 2004Actual

Completion Date

Jul 2004Actual

First Submitted Date

Mar 18, 2008

First Submission Date that Met QC Criteria

Mar 18, 2008

First Posted Date

Mar 24, 2008Estimated

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

Mar 24, 2009

Last Update Posted Date

Mar 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. The study will also determine which combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering blood pressure (without unacceptable side effects), and whether it is possible to combine both drugs in a single tablet to simplify blood pressure treatment.

Detailed Description

Not provided

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

1,900Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Metoprolol Succinate + Hydrochlorothiazide	Drug: Metoprolol Succinate Drug: Hydrochlorothiazide
2	Active Comparator	Metoprolol Succinate	Drug: Metoprolol Succinate
3	Active Comparator	Hydrochlorothiazide	Drug: Hydrochlorothiazide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metoprolol Succinate	Drug		1 2	TOPROL-XL
Hydrochlorothiazide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in trough sitting diastolic blood pressure		3 readings determined at 8 weeks after treatment

Secondary Outcomes

Measure	Description	Time Frame
change in trough Sitting Systolic Blood pressure		3 readings determined at 8 weeks after treatment
change in trough Standing Systolic Blood Pressure		6 readings determined at 8 weeks after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diastolic blood pressure between 95 and 114 mm at screening and start of treatment

Exclusion Criteria:

Significant conditions which in the opinion of the investigator place the subject at undue risk, eg Renal impairment, hepatitis
Known secondary causes of hypertension, eg, Cushing's syndrome, renal artery stenosis, pheochromocytoma, hyperaldosteronism
Systolic blood pressure greater or equal to 180 mm Hg at start of trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vasilios Papademetriou	Georgetown University	Principal Investigator

Locations

Not provided

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
D008790	Metoprolol
D006852	Hydrochlorothiazide

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided