Not Signed In -
Bisoprolol and Hydrochlorothiazide |
Ziac |
Clinical Trial: Olmesartan as an Add-on to Amlodipine in Hypertension
This study is not yet open for patient recruitment.
Verified by Sankyo Pharma Development September 2005
|
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Essential Hypertension | Drug: olmesartan medoxomil Drug: amlodipine Drug: hydrochlorothiazide | Phase III |
MedlinePlus related topics: High Blood Pressure
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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
Further Study Details:
Primary Outcomes: Mean change in trough seated diastolic blood pressure
Secondary Outcomes: 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
Expected Total Enrollment: 632
Secondary Outcomes: 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
Expected Total Enrollment: 632
Study start: October 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00220233
Petra Laeis, MD +49 (0) 89/7808-0
Germany
Tann, Germany
Leipzig, Germany
Sinsheim, Germany
Weinheim, Germany
Wiesbaden, Germany
Study chairs or principal investigators
Peter Brommer, MD, Principal Investigator, Unaffiliated
More Information
Study ID Numbers: CS8663-A-E303
Last Updated: September 21, 2005
Record first received: September 16, 2005
ClinicalTrials.gov Identifier: NCT00220233
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-27
Last Updated: September 21, 2005
Record first received: September 16, 2005
ClinicalTrials.gov Identifier: NCT00220233
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-27
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