Phase 3
N=846
Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00441350 ↗Enrolled (actual)
846
Serious AEs
0.9%
Results posted
Jul 2021
Primary outcome: Primary: dBP Change After 8 Weeks Phase A — -15.8; -18.9 mmHG — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OM 40 (Drug); OM/HCTZ 40/12.5 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Menarini Group
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY dBP Change After 8 Weeks Phase A |
-15.8; -18.9 | <0.0001 sig |
| PRIMARY sBP Change After 8 Weeks Phase A |
-26.5; -31.9 | < 0.0001 sig |
| SECONDARY dBP Change After 8 Weeks Phase B |
-0.5; -9.3; -0.3; -8.0 | < 0.0001 sig |
| SECONDARY sBP Change After 8 Weeks Phase B |
-0.5; -12.4; -0.4; -12.1 | 0.0001 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00441350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.