Ignite Creation Date:
2024-05-06 @ 3:00 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02175355
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-06-25
Brief Title:
Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis Telmisartan or Hydrochlorothiazide in the Management of Patients With Isolated Systolic Hypertension ISH
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Double- Blind Placebo-controlled 6 Week Parallel-group Trial on the Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis Telmisartan 20 mg 40 mg or 80 mg po Once Daily or Hydrochlorothiazide 125 mg po Once Daily in the Management of Patients With Isolated Systolic Hypertension ISH ARAMIS - Study Angiotensin II Receptor Antagonist Micardis in Isolated Systolic Hypertension
Status:
COMPLETED
Status Verified Date:
2014-07
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:
ARAMIS
Brief Summary:
Primary To identify doses of Micardistelmisartan which administered once daily are more effective than placebo and not inferior to HCTZ in lowering systolic blood pressure SBP in patients with isolated systolic hypertension ISH and to assess the dose response relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80 mg
Secondary Target fall in SBP change from baseline in seated DBP Safety and tolerability of Micardis and HCTZ in patients with ISH as measured by changes in physical examinations heart rate laboratory parameters andor 12-lead ECG as well as the incidence and severity of adverse events
Secondary Target fall in SBP change from baseline in seated DBP Safety and tolerability of Micardis and HCTZ in patients with ISH as measured by changes in physical examinations heart rate laboratory parameters andor 12-lead ECG as well as the incidence and severity of adverse events
Detailed Description:
None
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