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 BPMean 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
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