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Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

NCT ID: NCT00716950

Last Updated: 2008-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-02-28

Brief Summary

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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

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

valsartan/amlodipine

Group Type EXPERIMENTAL

valsartan/amlodpine

Intervention Type DRUG

tablets; 160mg/5mg; od; 4 weeks

2

losartan/amlodpine

Group Type ACTIVE_COMPARATOR

losartan/amlodpine

Intervention Type DRUG

tablets; 100mg/5mg; od; 4 weeks

Interventions

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valsartan/amlodpine

tablets; 160mg/5mg; od; 4 weeks

Intervention Type DRUG

losartan/amlodpine

tablets; 100mg/5mg; od; 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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University of Pavia

Principal Investigators

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Roberto Fogari, MD

Role: STUDY_CHAIR

University of Pavia

Locations

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Giuseppe Derosa

Pavia, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Roberto Fogari, MD

Role: CONTACT

Phone: +39 0382 526217

Email: [email protected]

Facility Contacts

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Giuseppe Derosa, MD

Role: primary

Other Identifiers

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UNIPV004DIM2008

Identifier Type: -

Identifier Source: org_study_id