HypertensionPhase 2NCT00376636
Phase IIa Safety and Efficacy Study of SPP635 in Mild to Moderate Hypertension
A Phase 2 study testing SPP635 (drug) in people with Hypertension, run by Speedel Pharma Ltd. at 1 site in Germany.
Trial summary
This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- SPP635 (drug)
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to May 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients with mild to moderate hypertension
Who cannot join
- female patients of child-bearing potential or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-Week Study to Investigate the Safety and Efficacy of the Oral Renin Inhibitor SPP635 Once Daily in Patients With Mild to Moderate Hypertension
This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.
Read the detailed description
Renin-Angiotensin system blockade is a well established target for treatment of high blood pressure. Blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor, SPP635.
- Conditions
- Hypertension
- Being tested
- SPP635 (drug)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPP635 (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowering of systolic office blood pressure
Measured: four weeks
Lowering of diastolic office blood pressure
Measured: four weeks
Secondary outcomes (1)
Lowering of systolic and diastolic blood pressure (ABPM)
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startOct 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Speedel Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sybille Baumann-Noss, MD, Principal investigator, IKP Bobenheim GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376636
- Sponsor's protocol ID
- SPP635CRD04
- Status last verified
- Sep 2006
- First submitted
- 14 Sep 2006
- Last updated
- 30 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-Week Study to Investigate the Safety and Efficacy of the Oral Renin Inhibitor SPP635 Once Daily in Patients With Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT00376636
- Acronym / sponsor ID
- SPP635CRD04
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Speedel Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- May 2007 (actual)
- First posted
- 15 Sep 2006 (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.
This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.
Detailed description
Renin-Angiotensin system blockade is a well established target for treatment of high blood pressure. Blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor, SPP635.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male or female patients with mild to moderate hypertension
Key exclusion criteria (1 listed)
- female patients of child-bearing potential or breast-feeding
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 |
|---|---|---|
| SPP635 (drug) | Drug | – |
Primary outcome
Lowering of systolic office blood pressure
Time frame: four weeks
Lowering of diastolic office blood pressure
Time frame: four weeks
1 secondary outcome
Lowering of systolic and diastolic blood pressure (ABPM)
Time frame: four weeks
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 30 Oct 2007.
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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.
Sybille Baumann-Noss, MD principal investigator
IKP Bobenheim GmbH
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 SPP635 (drug) in people with Hypertension, run by Speedel Pharma Ltd. at 1 site in Germany.
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 1 inclusion and 1 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 30 Oct 2007. 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 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. 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?
Lowering of systolic office blood pressure (time frame: four weeks). The study lists 2 primary outcomes in all. 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 30 Oct 2007.