Status:
COMPLETED
Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension
Lead Sponsor:
Menarini Group
Collaborating Sponsors:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 hypertensi...
Detailed Description
Methodology: After the signature of the informed consent, patients were screened for eligibility and eligible patients entered into a pre-randomisation period consisting of a taper-off phase of appro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
1004 Patients enrolled
Trial Details
Trial ID
NCT00441350
Start Date
July 1 2007
End Date
May 1 2008
Last Update
July 28 2021
Active Locations (65)
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1
Rijeka, Croatia
2
Slavonski Brod, Croatia
3
Split, Croatia
4
Varaždin, Croatia