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Amlodipine as Add-on to Olmesartan in Hypertension
This study has been completed.
Sponsor:
Sankyo Pharma Gmbh
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00220220
First received: September 16, 2005
Last updated: October 10, 2007
Last verified: October 2007
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.
Secondary Outcome Measures:
- Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.
- Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.
- Safety and tolerability
| Estimated Enrollment: | 429 |
| Study Start Date: | April 2005 |
| Study Completion Date: | April 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization.
Exclusion Criteria:
- Secondary hypertension of any aetiology;
- Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s);
- History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00220220
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220220
Locations
| Germany | |
| Hamburg, Germany | |
| Magdeburg, Germany | |
| Messkirch, Germany | |
| Stuhr, Germany | |
| Tann, Germany | |
| Worpswede, Germany | |
Sponsors and Collaborators
Sankyo Pharma Gmbh
Investigators
| Principal Investigator: | Peter Brommer, MD |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00220220 History of Changes |
| Other Study ID Numbers: |
CS8663-A-E302 |
| Study First Received: | September 16, 2005 |
| Last Updated: | October 10, 2007 |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Olmesartan Olmesartan Medoxomil Amlodipine Antihypertensive Agents |
Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents |
ClinicalTrials.gov processed this record on June 28, 2017