Additive Beneficial Effects of Atorvastatin Combined With... | NCT00741078

Studies
Additive Beneficial Effects of Atorvastatin Combined With Amlodipine In Treatment of Hypertension

NCT00741078

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Aug 29, 2008Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Hypertension

Interventions

statin, amlodipine

Countries

South Korea

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

Aug 2008

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

Dec 2004

Primary Completion Date

Not provided

Completion Date

Aug 2008Actual

First Submitted Date

Aug 20, 2008

First Submission Date that Met QC Criteria

Aug 25, 2008

First Posted Date

Aug 26, 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

Aug 28, 2008

Last Update Posted Date

Aug 29, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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 4

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
atorvastatin, amlodipine	Experimental		Drug: statin, amlodipine

Name	Type	Description	Arm Group Labels	Other Names
statin, amlodipine	Drug		atorvastatin, amlodipine

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hypertension

Exclusion Criteria:

Chronic renal disease
Severe hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gil Medical Center		Incheon		405-760	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D007333	Insulin Resistance
D006967	Hypersensitivity

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors
D017311	Amlodipine

Ancestor Terms

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action

Browse Leaves

Not provided

Browse Branches

Not provided