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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No.: 2007-007516-28 |
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The study medication CYT006-AngQb is a vaccine, consisting of angiotensin II (Ang II), the naturally occurring octapeptide coupled onto the surface of virus-like particles (VLP). This form of presenting Ang II to the immune system induces a B-cell mediated immune response characterized by the generation of specific antibodies (IgG and IgM) against Ang II. The CYT006-AngQb vaccine is administered by subcutaneous (s.c.) injection. Immunization against angiotensin II may offer a valuable alternative to conventional drugs for the treatment of hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CYT006-AngQb |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYT006-AngQb | Biological | s.c. injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events: quality, quantity, severity | throughout complete study until week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in daytime, nighttime and 24h ambulatory blood pressure from baseline | 24 hours | |
| anti-Angio II IgG antibody titer | throughout complete study until week 48 | |
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Inclusion Criteria:
Exclusion Criteria:
Patients with "very high added risk" according to 2007 Guidelines for the Management of Arterial Hypertension (Journal of Hypertension, 2007, 25:1105- 1187), i.e. those with:grade III hypertension (mean sitting office SBP
Electrocardiographic confirmed left ventricular hypertrophy
Increased plasma creatinine
Diabetes mellitus type I, history, presence or new diagnosis of diabetes mellitus type II.
Postural hypotension at screening
Arrhythmias that would interfere with the oscilloscopic measurement of the blood pressure.
Known autoimmune disease.
Severe allergy.
Pregnancy or breastfeeding.
Women in childbearing age that are not surgically sterilized.
Patients with a history or current positive test for HIV infection, AIDS, or other immunosuppressive disorders; hepatitis B or C.
Current diagnosis or history of malignancy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cytos Biotechnology (Sponsor's Headquarter) | Schlieren | CH-8952 | Switzerland |
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| ID | Term |
|---|---|
| C525491 | CYT006-AngQb |
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| Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone) |
| 24 h |