Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension
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
1 other identifier
interventional
1,004
8 countries
65
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Jul 2007
Shorter than P25 for phase_3 hypertension
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
February 28, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
July 28, 2021
CompletedJuly 28, 2021
June 1, 2009
10 months
February 27, 2007
May 6, 2021
July 8, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
dBP Change After 8 Weeks Phase A
Reduction in Mean Trough Sitting dBP (mmHg) from Baseline (Week 0) to Week 8
Eight weeks
sBP Change After 8 Weeks Phase A
Reduction in Mean Trough Sitting sBP (mmHg) from Baseline (Week 0) to Week 8
Eight weeks
Secondary Outcomes (2)
dBP Change After 8 Weeks Phase B
Eight weeks
sBP Change After 8 Weeks Phase B
Eight weeks
Study Arms (2)
OM 40
ACTIVE COMPARATOROlmesartanmedoxomil (OM)40 mg tablets.
OM/HCTZ 40/12.5
EXPERIMENTALOlmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Mean sitting dBP ≥ 100 mmHg and ≤ 120 mmHg.
- Mean sitting sBP ≥ 160 mmHg and ≤ 200 mmHg.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Unknown Facility
Rijeka, Croatia
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Slavonski Brod, Croatia
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Split, Croatia
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Varaždin, Croatia
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Zadar, Croatia
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Zagreb, Croatia
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Benátky nad Jizerou, Czechia
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Bílovec, Czechia
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Brodce, Czechia
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Jablonec nad Nisou, Czechia
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Mladá Boleslav, Czechia
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Prague, Czechia
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Rokycany, Czechia
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Tábor, Czechia
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Teplice, Czechia
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Uničov, Czechia
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Aalborg, Denmark
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Ballerup Municipality, Denmark
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Vejle, Denmark
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Berlin, Germany
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Cologne, Germany
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Dresden, Germany
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Einbeck, Germany
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Essen, Germany
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Giengen an der Brenz, Germany
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Großheirath, Germany
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Hamburg, Germany
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Hanau, Germany
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Heidelberg, Germany
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Künzing, Germany
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Leipzig, Germany
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Lollar, Germany
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Mannheim, Germany
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München, Germany
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Nuremberg, Germany
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Ashkelon, Israel
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Beersheba, Israel
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Haifa, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Nahariya, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Busto Arsizio, Italy
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Ferrara, Italy
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Pavia, Italy
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Pisa, Italy
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San Daniele del Friuli, Italy
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Sassari, Italy
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Somma Lombardo, Italy
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Venezia, Italy
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Bialystok, Poland
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Gdansk, Poland
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Gdynia, Poland
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Lublin, Poland
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Płock, Poland
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Warsaw, Poland
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Wąbrzeżno, Poland
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Baia Mare, Romania
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Brăila, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Oradea, Romania
Unknown Facility
Suceava, Romania
Related Publications (1)
Fogari R, Taddei S, Holm-Bentzen M, Baszak J, Melani L, Schumacher K. Efficacy and safety of olmesartan medoxomil 40 mg/hydrochlorothiazide 12.5 mg combination therapy versus olmesartan medoxomil 40 mg monotherapy in patients with moderate to severe hypertension: a randomized, double-blind, parallel-group, multicentre, multinational, phase III study. Clin Drug Investig. 2010;30(9):581-97. doi: 10.2165/11536710-000000000-00000.
PMID: 20593911DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela Capriati, MD PhD - Global Director Clinical Sciences
- Organization
- Menarini Group
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto Fogari, MD
Medical Clinic Policlinico San Matteo University of Pavia Italy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2007
First Posted
February 28, 2007
Study Start
July 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
July 28, 2021
Results First Posted
July 28, 2021
Record last verified: 2009-06
Data Sharing
- IPD Sharing
- Will not share