Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500786
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2007-07-12
Brief Title:
Safety Tolerability Pharmacodynamic Effects and Preliminary Evidence for Efficacy of the Anti-Hypertension Vaccine CYT006-AngQb
Sponsor:
Cytos Biotechnology AG
Organization:
Cytos Biotechnology AG
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-08
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:
This is a multi-center randomized placebo-controlled time-lagged parallel-group study in healthy and hypertensive subjects to evaluate safety and tolerability of the vaccine CYT006-AngQb The trial is double-blind for active vs placebo within each treatment arm but open with respect to AngQb dose escalation
In the first arm 16 healthy normotensive volunteers are treated with a one dose regimen consisting of a single sc injection of 100µg of AngQb or placebo Upon satisfying safety and tolerability profile as judged by the independent safety monitoring board arm two is enrolled
In arm two 36 patients with mild to moderate hypertension receive three sc injections of 100µg CYT006-AngQb 24 patients or placebo 12 patients The second and third injections are given 4 and 12 weeks after the first injection respectively Upon satisfying safety and tolerability profile as judged by the independent safety monitoring board arm three is enrolled
In arm three 36 patients with mild to moderate hypertension receive three sc injections of 300µg CYT006-AngQb 24 patients or placebo 12 patients The second and third injections are given 4 and 12 weeks after the first injection respectively
The primary objective of the trial is to evaluate safety tolerability of 3 dose regimens of CYT006-AngQb in healthy volunteers and patients with mild to moderate essential hypertension Secondary objectives include the assessment of pharmacodynamic effects and their dose-response immunogenicity and biomarkers of the renin-angiotensin system and the exploration of clinical efficacy effects on systolic and diastolic blood pressure
In the first arm 16 healthy normotensive volunteers are treated with a one dose regimen consisting of a single sc injection of 100µg of AngQb or placebo Upon satisfying safety and tolerability profile as judged by the independent safety monitoring board arm two is enrolled
In arm two 36 patients with mild to moderate hypertension receive three sc injections of 100µg CYT006-AngQb 24 patients or placebo 12 patients The second and third injections are given 4 and 12 weeks after the first injection respectively Upon satisfying safety and tolerability profile as judged by the independent safety monitoring board arm three is enrolled
In arm three 36 patients with mild to moderate hypertension receive three sc injections of 300µg CYT006-AngQb 24 patients or placebo 12 patients The second and third injections are given 4 and 12 weeks after the first injection respectively
The primary objective of the trial is to evaluate safety tolerability of 3 dose regimens of CYT006-AngQb in healthy volunteers and patients with mild to moderate essential hypertension Secondary objectives include the assessment of pharmacodynamic effects and their dose-response immunogenicity and biomarkers of the renin-angiotensin system and the exploration of clinical efficacy effects on systolic and diastolic blood pressure
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