Not Signed In -
Amlodipine and Benazepril |
Lotrel |
Clinical Trial: Amlodipine as Add-on to Olmesartan in Hypertension
This study is not yet open for patient recruitment.
Verified by Sankyo Pharma Development September 2005
|
Purpose
Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan alone.
| Condition | Intervention | Phase |
|---|---|---|
| Essential Hypertension | Drug: olmesartan medoxomil Drug: amlodipine | 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: Efficacy and Safety of Amlodipine Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 Mg Monotherapy
Further Study Details:
Primary Outcomes: Mean change in trough seated diastolic blood pressure at the end of the study compared to the start of the study
Secondary Outcomes: Mean change in daytime, nighttime and 24 hour ambulatory blood pressure; Percent of patients achieving target blood pressure goals; Safety and tolerability
Expected Total Enrollment: 429
Secondary Outcomes: Mean change in daytime, nighttime and 24 hour ambulatory blood pressure; Percent of patients achieving target blood pressure goals; Safety and tolerability
Expected Total Enrollment: 429
Study start: September 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Without antihypertensive pre-treatment: mean sittting BP greater than or equal to 160/100 mmHg
- Pre-treatment with olmesartan medoxomil 20 or 40 mg: mean sitting BP of 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 NCT00220220
Petra Laeis, MD +49 (0) 89/7808-0
Germany
Tann, Germany
Hamburg, Germany
Magdeburg, Germany
Messkirch, Germany
Stuhr, Germany
Worpswede, Germany
Study chairs or principal investigators
Peter Brommer, MD, Principal Investigator, Unaffiliated
More Information
Study ID Numbers: CS8663-A-E302
Last Updated: September 21, 2005
Record first received: September 16, 2005
ClinicalTrials.gov Identifier: NCT00220220
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: NCT00220220
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-27
Resources
- Amlodipine and Benazepril (Drug Digest)
- Lotrel (Drug Digest)
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