Valsartan and Amlodipine Compared to Losartan and Amlodip... | NCT00716950

Studies
Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

NCT00716950

Sponsor

University of Pavia

Status

Unknown status

Last Update Posted

Jul 17, 2008Estimated

Enrollment

187Estimated

Phase

Phase 4

Conditions

Essential Hypertension

Interventions

valsartan/amlodpine
losartan/amlodpine

Countries

Italy

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

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Feb 2009Estimated

Completion Date

Feb 2009Estimated

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 14, 2008

First Posted Date

Jul 16, 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

Jul 16, 2008

Last Update Posted Date

Jul 17, 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

Description Module

Brief Summary

Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.

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

187Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	valsartan/amlodipine	Drug: valsartan/amlodpine
2	Active Comparator	losartan/amlodpine	Drug: losartan/amlodpine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
valsartan/amlodpine	Drug	tablets; 160mg/5mg; od; 4 weeks	1
losartan/amlodpine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment		after 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM		after 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure > 140 mmHg at the end of the selection period

Exclusion Criteria:

type 2 diabetes mellitus
heart failure
AMI in the previous 6 months
angina pectoris
secondary hypertension
malignant hypertension
women child-bearing potential
women who are pregnant and lactating
suspected history of allergy to the sartans or calcium channels blockers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roberto Fogari, MD	Contact	+39 0382 526217		r.fogari@unipv.it

Overall Officials

Name	Affiliation	Role
Roberto Fogari, MD	University of Pavia	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Giuseppe Derosa	Recruiting	Pavia		27100	Italy

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
D000068756	Valsartan
D019808	Losartan

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided