Amlodipine as add-on to Olmesartan in Hypertension
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ClinicalTrials.gov Identifier: NCT00220220 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : December 24, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Essential Hypertension | Drug: olmesartan medoxomil Drug: amlodipine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 429 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | April 2005 |
Actual Study Completion Date : | April 2007 |

- Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220220
Germany | |
Hamburg, Germany | |
Magdeburg, Germany | |
Messkirch, Germany | |
Stuhr, Germany | |
Tann, Germany | |
Worpswede, Germany |
Principal Investigator: | Peter Brommer, MD |
ClinicalTrials.gov Identifier: | NCT00220220 |
Other Study ID Numbers: |
CS8663-A-E302 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | December 24, 2018 |
Last Verified: | October 2007 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. |
Access Criteria: | Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. |
URL: | https://vivli.org/ourmember/daiichi-sankyo/ |
Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Olmesartan Olmesartan Medoxomil Antihypertensive Agents |
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