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”

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.

Study Type: Interventional

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

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: OM 40
  • Olmesartanmedoxomil (OM)40 mg tablets.
• Experimental: OM/HCTZ 40/12.5
  • Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.

Primary Measures

• Change in diastolic blood pressure.
  • Time Frame: Between baseline and week 8
    Safety Issue?: No

Secondary Measures

• Change in diastolic blood pressure among non-responders to primary therapy.
  • Time Frame: Between week 8 and week 16.
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Menarini Group

Overall Clinical Trial Officials and Contacts

Roberto Fogari, MD Principal Investigator Medical Clinic Policlinico San Matteo University of Pavia Italy  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00441350

Study ID Number: CS866CM-B-E303

ClinicalTrials.gov Identifier: NCT00441350

Health Authority: Croatia: Ministry of Health and Social Care