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Olmesartan as an Add-on to Amlodipine in Hypertension

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: olmesartan medoxomil (Drug); amlodipine (Drug); hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sankyo Pharma Gmbh

Official(s) and/or principal investigator(s):
Peter Brommer, MD, Principal Investigator

Summary

This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone

Clinical Details

Official title: Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean change in trough seated diastolic blood pressure

Secondary outcome:

Mean change in trough seated systolic BP

Mean change in daytime, nighttime and 24 hour ambulatory blood pressure

Percent of patients achieving target blood pressure goal

Safety and tolerability

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg

- Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to

140/90 mmHg Exclusion Criteria:

- Secondary hypertension

- Any serious disorder which may limit the ability to evaluate the efficacy or safety

of the test drugs

Locations and Contacts

Leipzig, Germany

Sinsheim, Germany

Tann, Germany

Weinheim, Germany

Wiesbaden, Germany

Additional Information

Starting date: April 2005
Last updated: December 12, 2007

Page last updated: August 20, 2015

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