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HypertensionPhase 2NCT00701649

Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of a Vaccine Against Essential Hypertension

A Phase 2 study testing CYT006-AngQb in people with Hypertension, run by Cytos Biotechnology AG at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 s.c. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Hypertension
What is being tested?
CYT006-AngQb
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
6 sitesin 2 countries
Study dates
Mar 2008to Nov 2009
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 screening ABPM measurement (SBP >135 mmHg).
  • Patients without current antihypertensive therapy.
  • Patients on antihypertensive therapy, which can be stopped.
  • 18 to 69 years of age.
  • Male patients, or female patients without childbearing potential .

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 mean sitting 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, heart failure
  • Peripheral artery disease
Show all 22Show fewer
  • Diabetic nephropathy
  • 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.
  • Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
  • Drug or alcohol abuse within the past 2 years.
  • Presence or history of relevant cardiovascular, renal, hepatic, pulmonary, endocrine, autoimmune, neurological and psychiatric disease as judged by the investigator.
  • Any current or past disease or conditions (physical or mental) that would, in the opinion of the investigator, interfere with the study procedures or interpretation of the study data (e.g. workers in the night shift).
  • Previous participation in a clinical trial with a Qb based vaccine.
  • Use of an investigational drug within 3 months before enrolment, or planned use during the whole study period.
  • Possible dependency of the patient on sponsor and/or investigator.
  • Planned active immunization 2 weeks before or 2 weeks after any study medication vaccination.
  • Donation or loss >=400 mL of blood within 8 weeks prior to dosing or major surgery within past 2 months.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Switzerland4 sites

  • University Hospital Basel

    Basel, CH-4031

  • Inselspital

    Bern, CH-3010

  • Hopital Universitaire Geneve

    Geneva, CH-1211

  • Med Zentrum Römerhof

    Zurich, CH-8091

Other trials in Switzerland

Germany2 sites

  • CRS Mannheim

    Mannheim, D-68167

  • CRS Mönchengladbach

    Mönchengladbach, D-41061

Other trials in Germany

About this study

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

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 s.c. injections of 300µg CYT006-AngQb with Alhydrogel™ in patients with mild to moderate essential hypertension (hypertension Grade I and II).
  • To assess pharmacodynamic effects, i.e. anti-Ang II immune response and renin- angiotensin system (RAS) biomarkers.
  • To explore the effect on blood pressure using ABPM.
Conditions
Hypertension
Being tested
CYT006-AngQb, Placebo
Keywords
mild essential hypertension, moderate essential hypertension
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CYT006-AngQbBiological

    s.c.

  • PlaceboBiological

    s.c.

Study groups in NCT00701649
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Biological: CYT006-AngQb
2Placebo comparatorNot described
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events: quality, quantity, severity

    Measured: Throughout the study until week 48

Secondary outcomes (3)

  1. Change in daytime, nighttime and 24-hour ambulatory blood pressure from baseline

    Measured: 24 hours

  2. Titer of IgG specific for angiotensin II

    Measured: Throughout the study untill week 48

  3. Amount of RAS-Biomarkers (plasma renin concentration, angiotensin II, aldosterone)

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMar 2009
  4. Study completionNov 2009

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00701649
Sponsor's protocol ID
CYT006-AngQb 02
Other IDs
Eudract No. 2007-005843-93
Status last verified
Dec 2009
First submitted
18 Jun 2008
Last updated
2 Dec 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CYT006-AngQb in people with Hypertension, run by Cytos Biotechnology AG at 6 sites in 2 countries.

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 6 inclusion and 22 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 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland, Germany. 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 the study until week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00701649.

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 2 Dec 2009.

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