Mild Essential HypertensionPhase 2NCT00710372
Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension
A Phase 2 study testing CYT006-AngQb in people with Mild Essential Hypertension and Moderate Essential Hypertension, run by Cytos Biotechnology AG at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Mild Essential Hypertension, Moderate Essential Hypertension
- What is being tested?
- CYT006-AngQb
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2008to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to moderate essential hypertension (Grade I and Grade II) with mean sitting office SBP =140-179 mmHg and/or mean sitting office DBP = 90 -109 mmHg on 2 consecutive visits (screening and V1).
- Daytime blood pressure above threshold for definition of hypertension in the baseline ABPM measurement (SBP >135 mmHg).
- Stable baseline blood pressure confirmed on 2 consecutive visits (screening and V1). (Changes <20mmHg for sitting office SBP and <10mmHg for mean sitting office DPB).
- Patients without current antihypertensive therapy. Patients on previous mono-antihypertensive therapy, who can safely stop their medication
- Patient is willing and able to comply with all trial requirements and procedures.
Who cannot join
- 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
- 180mmHg and/or meansitting DBP ≥110mmHg/history or presence of established cardiovascular or renal disease (Ischemic stroke, cerebral hemorrhage, transient ischemic attack)/ Myocardial infarction, angina pectoris, coronary re-vascularization/ clinically relevant heart failure (NYHA class II-IV)/ Peripheral artery disease/ Diabetic nephropathy
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cytos Biotechnology (Sponsor's Headquarter)
Schlieren, CH-8952
About this study
Official title: A Double Blind, Randomized, Placebo Controlled, Parallel Group, Dose-Titration Phase II Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Efficacy of an Anti-Angiotensin II Vaccine (CYT006-AngQb) in Patients With Mild to Moderate Essential Hypertension
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.
- Being tested
- CYT006-AngQb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT006-AngQbBiological
s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CYT006-AngQb Receives: Biological: CYT006-AngQb |
| 2 | Placebo comparator | Not described Receives: Biological: CYT006-AngQb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events: quality, quantity, severity
Measured: throughout complete study until week 48
Secondary outcomes (3)
Change in daytime, nighttime and 24h ambulatory blood pressure from baseline
Measured: 24 hours
anti-Angio II IgG antibody titer
Measured: throughout complete study until week 48
Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710372
- Sponsor's protocol ID
- CYT006-AngQb 03
- Other IDs
- EudraCT No.: 2007-007516-28
- Status last verified
- Nov 2010
- First submitted
- 3 Jul 2008
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled, Parallel Group, Dose-Titration Phase II Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Efficacy of an Anti-Angiotensin II Vaccine (CYT006-AngQb) in Patients With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT00710372
- Acronym / sponsor ID
- CYT006-AngQb 03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CYT006-AngQbCYT006-AngQb |
| 2 | Placebo comparator | Biological: CYT006-AngQb |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with mild to moderate essential hypertension (Grade I and Grade II) with mean sitting office SBP =140-179 mmHg and/or mean sitting office DBP = 90 -109 mmHg on 2 consecutive visits (screening and V1).
- Daytime blood pressure above threshold for definition of hypertension in the baseline ABPM measurement (SBP >135 mmHg).
- Stable baseline blood pressure confirmed on 2 consecutive visits (screening and V1). (Changes <20mmHg for sitting office SBP and <10mmHg for mean sitting office DPB).
- Patients without current antihypertensive therapy. Patients on previous mono-antihypertensive therapy, who can safely stop their medication
- Patient is willing and able to comply with all trial requirements and procedures.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYT006-AngQbs.c. injection | Biological | 1, 2 |
Primary outcome
Adverse events: quality, quantity, severity
Time frame: throughout complete study until week 48
3 secondary outcomes
Change in daytime, nighttime and 24h ambulatory blood pressure from baseline
Time frame: 24 hours
anti-Angio II IgG antibody titer
Time frame: throughout complete study until week 48
Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)
Time frame: 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYT006-AngQb in people with Mild Essential Hypertension and Moderate Essential Hypertension, run by Cytos Biotechnology AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events: quality, quantity, severity (time frame: throughout complete study until week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.