Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension - Full Text View

Sponsors and Collaborators:	Menarini Group Daiichi Sankyo Europe, GmbH
Information provided by:	Menarini Group
ClinicalTrials.gov Identifier:	NCT00441350

Purpose

The primary objective of this study is 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 consists of two sequential phases of 8 weeks duration each:

During the first phase, OM 40 mg monotherapy will be 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 proves to be insufficiently controlled by the OM 40 mg monotherapy will 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 will be up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the up-titrated combination.

The study will 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	Intervention	Phase
Hypertension	Drug: OM 40 Drug: OM/HCTZ 40/12.5	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Menarini Group:

Primary Outcome Measures:

Change in diastolic blood pressure. [ Time Frame: Between baseline and week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in diastolic blood pressure among non-responders to primary therapy. [ Time Frame: Between week 8 and week 16. ] [ Designated as safety issue: No ]

Estimated Enrollment:	1400
Study Start Date:	July 2007
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
OM 40: Active Comparator Olmesartanmedoxomil (OM)40 mg tablets.	Drug: OM 40 Initially patients will be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders will be uptitrated to OM/HCTZ 40/12.5 mg and responders will remain on the previous therapy for further 8 weeks.
OM/HCTZ 40/12.5: Experimental Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.	Drug: OM/HCTZ 40/12.5 Initially patients will be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders will be uptitrated to OM/HCTZ 40/25 mg and responders will remain on the previous therapy for further 8 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party:	Menarini Ricerche S.p.A. ( Monica Bertolotti )
Study ID Numbers:	CS866CM-B-E303
Study First Received:	February 27, 2007
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00441350
Health Authority:	Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Israel: Ministry of Health; Italy: Ministry of Health; Poland: Ministry of Health; Romania: National Medicines Agency

Study placed in the following topic categories:

Vascular Diseases
Olmesartan medoxomil
Essential hypertension

Angiotensin II
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Sodium Chloride Symporter Inhibitors

Physiological Effects of Drugs
Diuretics
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009