Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension
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|ClinicalTrials.gov Identifier: NCT00441350|
Recruitment Status : Completed
First Posted : February 28, 2007
Last Update Posted : June 4, 2009
The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic BP in hypertensive patients after 8 weeks of double-blind treatment.
The study consisted of two sequential phases of 8 weeks duration each:
During the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate to severe hypertension.
During the second phase, patients whose BP proved to be insufficiently controlled by the OM 40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the up-titrated combination.
The study was be conducted by qualified and experienced personnel with adherence to GCP, current guidelines on the design of studies in hypertension, the applicable regulatory requirements and the ethical principles based on the Declaration of Helsinki.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: OM 40 Drug: OM/HCTZ 40/12.5||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1004 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Patients With Essential Hypertension|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Active Comparator: OM 40
Olmesartanmedoxomil (OM)40 mg tablets.
Drug: OM 40
Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.
Experimental: OM/HCTZ 40/12.5
Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.
Drug: OM/HCTZ 40/12.5
Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.
- Change in diastolic blood pressure. [ Time Frame: Between baseline and week 8 ]
- Change in diastolic blood pressure among non-responders to primary therapy. [ Time Frame: Between week 8 and week 16. ]
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): NCT00441350
|Tel-Aviv Sourasky Medical Center, Internal Medicine Ward D|
|Tel-Aviv, Israel, 64239|
|Principal Investigator:||Roberto Fogari, MD||Medical Clinic Policlinico San Matteo University of Pavia Italy|