Ignite Creation Date:
2024-05-05 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00701649
Status:
COMPLETED
Last Update Posted:
2009-12-02
First Post:
2008-06-18
Brief Title:
Study to Evaluate Safety and Tolerability Pharmacodynamic Effects and Exploratory Efficacy of a Vaccine Against Essential Hypertension
Sponsor:
Cytos Biotechnology AG
Organization:
Cytos Biotechnology AG
Study Overview
Official Title:
A Double Blind Randomized Placebo Controlled Parallel Group Phase IIa Study to Evaluate Safety and Tolerability Pharmacodynamic Effects and Exploratory Efficacy of an Anti-Angiotensin II Vaccine CYT006-AngQb in Patients With Mild to Moderate Essential Hypertension
Status:
COMPLETED
Status Verified Date:
2009-12
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:
CYT006-AngQb is a vaccine that induces a B-cell mediated immune response characterized by the generation of specific antibodies IgG and IgM against Angiotensin II The vaccine is administered by subcutaneous injection
The objectives of the study are
To evaluate safety and tolerability of 5 sc injections of 300µg CYT006-AngQb with Alhydrogel in patients with mild to moderate essential hypertension hypertension Grade I and II
To assess pharmacodynamic effects ie anti-Ang II immune response and renin- angiotensin system RAS biomarkers
To explore the effect on blood pressure using ABPM
The objectives of the study are
To evaluate safety and tolerability of 5 sc injections of 300µg CYT006-AngQb with Alhydrogel in patients with mild to moderate essential hypertension hypertension Grade I and II
To assess pharmacodynamic effects ie anti-Ang II immune response and renin- angiotensin system RAS biomarkers
To explore the effect on blood pressure using ABPM
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudract No 2007-005843-93 | None | None | None |