Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441350
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2007-02-27
Brief Title:
OlmesartanHCTZ 40125 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension
Sponsor:
Menarini Group
Organization:
Menarini Group
Study Overview
Official Title:
Phase III Study Evaluating the Efficacy and Safety of Olmesartan MedoxomilHydrochlorothiazide 40125 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Patients With Essential Hypertension
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study was to assess the anti-hypertensive effect of OMHCTZ 40125 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 OMHCTZ 40125 mg in order to evaluate the additional benefit of OMHCTZ 40125 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 OMHCTZ 40125 mg combination therapy while patients whose BP proved to be insufficiently controlled by the OMHCTZ 40125 mg combination were to be up-titrated to the OMHCTZ 4025 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
The study consisted of two sequential phases of 8 weeks duration each
During the first phase OM 40 mg monotherapy was compared with OMHCTZ 40125 mg in order to evaluate the additional benefit of OMHCTZ 40125 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 OMHCTZ 40125 mg combination therapy while patients whose BP proved to be insufficiently controlled by the OMHCTZ 40125 mg combination were to be up-titrated to the OMHCTZ 4025 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
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 approximately 1-2 weeks during which patients treated for hypertension were to discontinue their antihypertensive therapy followed by a 2-week single-blind placebo run-in phase Visit 1 After conclusion of the placebo run-in phase Visit 2 eligible patients were randomised to the double-blind active treatment period which consisted of two phases
First double-blind treatment phase Phase A from Randomisation to Week 8
Eligible patients with mean sitting sBP 160 and 200 mmHg and dBP 100 mmHg and 120 mmHg were randomised in a 12 ratio to receive either OM 40 mg or OMHCTZ 40125 mg for a total of 8 weeks of treatment Phase A Study visits were held after 4 and 8 weeks of double-blind active treatment Visit 3 and 4 respectively After 8 weeks Visit 4 patients reaching the BP goal of 14090 mmHg or 13080 mmHg for diabetics were considered as responders All patients responders and non-responders then entered into the titration phase of the study Phase B
Second double-blind treatment phasetitration phase Phase B from Week 8 to Week 16
Treatment assignment in the second part of the study was based on the following criteria
Responders to Phase A treatment continued to receive the same double-blind treatment for an additional 8 weeks
Non-responders Phase A treatment had their treatment assigned as follows
Non-responders to OM 40 mg were treated with OMHCTZ 40125 mg for an additional 8 weeks
Non-responders to OMHCTZ 40125 mg were uptitrated to OMHCTZ 4025 mg for an additional 8 weeks During Phase B of the study visits were held 12 and 16 weeks after randomisation Visits 5 and 6 respectively
The study ended at Visit 6 and a final examination was performed A safety follow-up SFU telephone contact was performed 2 weeks after the end of the treatment An SFU visit was performed if deemed necessary by the investigator
Sphygmomanometer was used for BP measurement throughout the trial BP was measured at all visits as nearly as possible at the same time of the day as trough readings 24 2 h after last drug intake after a 10 minute rest period Three separate sitting BP measurements were taken at least 1 minute apart from each other The 3 results were then averaged and rounded to a whole integer
Patients with sBP values 200 mmHg andor dBP values 120 mmHg at any time during the study were to be discontinued from the study
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 approximately 1-2 weeks during which patients treated for hypertension were to discontinue their antihypertensive therapy followed by a 2-week single-blind placebo run-in phase Visit 1 After conclusion of the placebo run-in phase Visit 2 eligible patients were randomised to the double-blind active treatment period which consisted of two phases
First double-blind treatment phase Phase A from Randomisation to Week 8
Eligible patients with mean sitting sBP 160 and 200 mmHg and dBP 100 mmHg and 120 mmHg were randomised in a 12 ratio to receive either OM 40 mg or OMHCTZ 40125 mg for a total of 8 weeks of treatment Phase A Study visits were held after 4 and 8 weeks of double-blind active treatment Visit 3 and 4 respectively After 8 weeks Visit 4 patients reaching the BP goal of 14090 mmHg or 13080 mmHg for diabetics were considered as responders All patients responders and non-responders then entered into the titration phase of the study Phase B
Second double-blind treatment phasetitration phase Phase B from Week 8 to Week 16
Treatment assignment in the second part of the study was based on the following criteria
Responders to Phase A treatment continued to receive the same double-blind treatment for an additional 8 weeks
Non-responders Phase A treatment had their treatment assigned as follows
Non-responders to OM 40 mg were treated with OMHCTZ 40125 mg for an additional 8 weeks
Non-responders to OMHCTZ 40125 mg were uptitrated to OMHCTZ 4025 mg for an additional 8 weeks During Phase B of the study visits were held 12 and 16 weeks after randomisation Visits 5 and 6 respectively
The study ended at Visit 6 and a final examination was performed A safety follow-up SFU telephone contact was performed 2 weeks after the end of the treatment An SFU visit was performed if deemed necessary by the investigator
Sphygmomanometer was used for BP measurement throughout the trial BP was measured at all visits as nearly as possible at the same time of the day as trough readings 24 2 h after last drug intake after a 10 minute rest period Three separate sitting BP measurements were taken at least 1 minute apart from each other The 3 results were then averaged and rounded to a whole integer
Patients with sBP values 200 mmHg andor dBP values 120 mmHg at any time during the study were to be discontinued from the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None