Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
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|ClinicalTrials.gov Identifier: NCT00561171|
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : November 21, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Type II Diabetes Mellitus||Drug: SPP635||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2007|
|Primary Completion Date :||September 2008|
|Study Completion Date :||September 2008|
oral once daily
oral once daily
- ABPM [ Time Frame: 28 days ]
- sitting PB [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561171
|Dr. John Barton|
|Ballinasloe, Co Galway, Ireland|
|Study Director:||Maria Nicolaides, Dr.||Speedel Pharma Ltd.|