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Sponsored by: |
Speedel Pharma Ltd. |
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Information provided by: | Speedel Pharma Ltd. |
ClinicalTrials.gov Identifier: | NCT00561171 |
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 | Intervention | Phase |
---|---|---|
Hypertension Type II Diabetes Mellitus |
Drug: SPP635 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | November 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
high dose
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Drug: SPP635
oral once daily
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2: Experimental
lower dose
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Drug: SPP635
oral once daily
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novartis Pharma AG ( Rolf Schlosshauer / Expert Clinical Manager ) |
Study ID Numbers: | SPP635CRD05 |
Study First Received: | November 19, 2007 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00561171 |
Health Authority: | Ireland: Irish Medicines Board; Hungary: National Institute of Pharmacy |
Albuminuria Metabolic Diseases Urination Disorders Diabetes Mellitus Vascular Diseases Endocrine System Diseases Signs and Symptoms |
Proteinuria Urologic Diseases Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Hypertension |
Urological Manifestations Cardiovascular Diseases |