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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
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Collaborator:
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Study Description
Brief Summary:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1004 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Primary Completion Date : May 2008
Study Completion Date : May 2008

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Change in diastolic blood pressure. [ Time Frame: Between baseline and week 8 ]

Secondary Outcome Measures :
  1. Change in diastolic blood pressure among non-responders to primary therapy. [ Time Frame: Between week 8 and week 16. ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of essential hypertension, either treatment-naive or including currently on anti-hypertensive medication (in Italy only treatment naive patients) in whom it is medically justifiable to withdraw treatment , and who are likely to meet the required BP inclusion criteria at randomisation:

    • Mean sitting dBP ≥ 100 mmHg and ≤ 120 mmHg.
    • Mean sitting sBP ≥ 160 mmHg and ≤ 200 mmHg.

Main Exclusion Criteria:

  • Mean sitting sBP values > 200 mmHg and/or dBP > 120 mmHg.
  • Pregnant or nursing women.
  • Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the tested medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological, oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients.
  • Patients with secondary hypertension of any aetiology such as renal disease, pheochromocytoma, or Cushing's syndrome.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Israel
Tel-Aviv Sourasky Medical Center, Internal Medicine Ward D
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Menarini Group
Daiichi Sankyo Europe, GmbH
Investigators
Principal Investigator: Roberto Fogari, MD Medical Clinic Policlinico San Matteo University of Pavia Italy
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Monica Bertolotti, Menarini Ricerche S.p.A.
ClinicalTrials.gov Identifier: NCT00441350     History of Changes
Other Study ID Numbers: CS866CM-B-E303
First Posted: February 28, 2007    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Hydrochlorothiazide
Olmesartan Medoxomil
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists