HypertensionPhase 2NCT00561171
Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
A Phase 2 study testing SPP635 in people with Hypertension and Type II Diabetes Mellitus, run by Speedel Pharma Ltd. at 1 site in Ireland.
Trial summary
This is a phase II a, double-blind, randomized, parallel-design, four-week study to investigate the efficacy, safety and tolerability of two different doses of SPP635 in type II diabetic patients with mild to moderate hypertension and albuminuria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Type II Diabetes Mellitus
- What is being tested?
- SPP635
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2007to Sep 2008
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women, 18 to 75 years
- hypertension
- diabetes mellitus type II
- albuminuria
Who cannot join
- donation of blood in the past month
- significant illness
- history of malignancy
- Heart failure, stroke, myocardial infarction, transient ischaemic attack, or hypertensive encephalopathy within the past 6 months
- Current or past history of clinically significant electrocardiogram (ECG) abnormalities such as permanent 2nd degree atrioventricular (AV) block or higher, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) or cerebrovascular accident in the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, Double-Blind, Randomized, Parallel-Design, Four-Week Study to Investigate the Efficacy and Safety of Two Different Doses of the Renin-Inhibitor SPP635 Once Daily in Type II Diabetic Patients With Mild to Moderate Hypertension and Albuminuria
This is a phase II a, double-blind, randomized, parallel-design, four-week study to investigate the efficacy, safety and tolerability of two different doses of SPP635 in type II diabetic patients with mild to moderate hypertension and albuminuria.
The total study duration for patients completing the entire study will be approximately 7 weeks including a 2 weeks Screening Phase, 1 week Wash-out Phase, 4 week Treatment Phase and 1 week Follow-up Phase.
Read more
All treatments other than certain antihypertensive drugs (which are to be washed-out) with an effect on BP and all antidiabetic treatments must be kept at stable dose during the whole study.
A maximum of 50 patients in total is planned to be enrolled.
- Conditions
- Hypertension, Type II Diabetes Mellitus
- Being tested
- SPP635
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPP635Drug
oral once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | high dose Receives: Drug: SPP635 |
| 2 | Experimental | lower dose Receives: Drug: SPP635 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABPM
Measured: 28 days
Secondary outcomes (1)
sitting PB
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionSep 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Speedel Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maria Nicolaides, Dr., Study director, Speedel Pharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561171
- Sponsor's protocol ID
- SPP635CRD05
- Status last verified
- Nov 2008
- First submitted
- 19 Nov 2007
- Last updated
- 21 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Double-Blind, Randomized, Parallel-Design, Four-Week Study to Investigate the Efficacy and Safety of Two Different Doses of the Renin-Inhibitor SPP635 Once Daily in Type II Diabetic Patients With Mild to Moderate Hypertension and Albuminuria
- ClinicalTrials.gov ID
- NCT00561171
- Acronym / sponsor ID
- SPP635CRD05
- Conditions
- Hypertension, Type II Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Speedel Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Nov 2007 (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 is a phase II a, double-blind, randomized, parallel-design, four-week study to investigate the efficacy, safety and tolerability of two different doses of SPP635 in type II diabetic patients with mild to moderate hypertension and albuminuria.
The total study duration for patients completing the entire study will be approximately 7 weeks including a 2 weeks Screening Phase, 1 week Wash-out Phase, 4 week Treatment Phase and 1 week Follow-up Phase.
All treatments other than certain antihypertensive drugs (which are to be washed-out) with an effect on BP and all antidiabetic treatments must be kept at stable dose during the whole study.
A maximum of 50 patients in total is planned to be enrolled.
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 | Drug: SPP635high dose |
| 2 | Experimental | Drug: SPP635lower dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men or women, 18 to 75 years
- hypertension
- diabetes mellitus type II
- albuminuria
Key exclusion criteria (5 listed)
- donation of blood in the past month
- significant illness
- history of malignancy
- Heart failure, stroke, myocardial infarction, transient ischaemic attack, or hypertensive encephalopathy within the past 6 months
- Current or past history of clinically significant electrocardiogram (ECG) abnormalities such as permanent 2nd degree atrioventricular (AV) block or higher, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) or cerebrovascular accident in the last three months
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 |
|---|---|---|
| SPP635oral once daily | Drug | 1, 2 |
Primary outcome
ABPM
Time frame: 28 days
1 secondary outcome
sitting PB
Time frame: 28 days
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 21 Nov 2008.
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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.
Maria Nicolaides, Dr. study director
Speedel Pharma Ltd.
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 in people with Hypertension and Type II Diabetes Mellitus, run by Speedel Pharma Ltd. at 1 site in Ireland.
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 4 inclusion and 5 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 21 Nov 2008. 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 Ireland. 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?
ABPM (time frame: 28 days). 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 21 Nov 2008.