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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 19, 2007 | ||||
| Last Updated Date | November 20, 2008 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
ABPM [ Time Frame: 28 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
ABPM [ Time Frame: 28 days ] | ||||
| Change History | Complete list of historical versions of study NCT00561171 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
sitting PB [ Time Frame: 28 days ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
sitting PB [ Time Frame: 28 days ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: SPP635 | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Ireland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00561171 | ||||
| Responsible Party | Rolf Schlosshauer / Expert Clinical Manager, Novartis Pharma AG | ||||
| Study ID Numbers ICMJE | SPP635CRD05 | ||||
| Study Sponsor ICMJE | Speedel Pharma Ltd. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Speedel Pharma Ltd. | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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