Efficacy and Safety of Levamlodipine Besylate Compared to... | NCT01131546

Studies
Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension

NCT01131546

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jun 1, 2011Estimated

Enrollment

1,080Estimated

Phase

Phase 4

Conditions

Essential Hypertension

Interventions

Levamlodipine besylate
Amlodipine maleate

Countries

China

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

May 2011

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 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

May 25, 2010

First Submission Date that Met QC Criteria

May 25, 2010

First Posted Date

May 27, 2010Estimated

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

May 30, 2011

Last Update Posted Date

Jun 1, 2011Estimated

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

This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,080Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Levamlodipine besylate (2.5mg)	Experimental	Drug: Levamlodipine besylate
Levamlodipine besylate (5mg)	Experimental	Drug: Levamlodipine besylate
Amlodipine maleate (5mg)	Active Comparator	Drug: Amlodipine maleate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levamlodipine besylate	Drug	Once daily, 7AM - 10AM	Levamlodipine besylate (2.5mg) Levamlodipine besylate (5mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients)		Week 8

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in systolic blood pressure (SBP)		Week 8
Change from baseline in diastolic blood pressure (DBP)		Week 8
Incidence of adverse effects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female outpatients, 18-75 Years
Patients with mild to moderate essential hypertension (defined as mean BP of 2 visits ≥140mm/90mmHg, and < 180mm/110mmHg)
Written informed consent

Exclusion Criteria:

Patients with secondary hypertension
Patients with severe hypertension
Have to take other drugs that can influence blood pressure during the study
Allergic to DHP calcium antagonists
Evidence of congestive heart failure, unstable angina or severe arrhythmia
Renal or hepatic dysfunction
Women who are taking contraceptive pills or are likely to be pregnant
Participate in other clinical trials within 3 months prior to this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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

Name	Affiliation	Role
Dayi Hu, MD	Peking University People's Hospital	Principal Investigator
Jinming Yu, Ph.D.	School of Public Health，Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital		Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension

Ancestor Terms

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000711385	levamlodipine besylate
D017311	Amlodipine

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided