Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
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
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hypertension
Started Nov 2007
Shorter than P25 for phase_2 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 19, 2007
CompletedFirst Posted
Study publicly available on registry
November 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedNovember 21, 2008
November 1, 2008
10 months
November 19, 2007
November 20, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
ABPM
28 days
Secondary Outcomes (1)
sitting PB
28 days
Study Arms (2)
1
EXPERIMENTALhigh dose
2
EXPERIMENTALlower dose
Interventions
Eligibility Criteria
You may qualify if:
- men or women, 18 to 75 years
- hypertension
- diabetes mellitus type II
- albuminuria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. John Barton
Ballinasloe, Co Galway, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maria Nicolaides, Dr.
Speedel Pharma Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 19, 2007
First Posted
November 20, 2007
Study Start
November 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
November 21, 2008
Record last verified: 2008-11