Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561171
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : November 21, 2008
Information provided by:
Speedel Pharma Ltd.

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.

Condition or disease Intervention/treatment Phase
Hypertension Type II Diabetes Mellitus Drug: SPP635 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
high dose
Drug: SPP635
oral once daily
Experimental: 2
lower dose
Drug: SPP635
oral once daily

Primary Outcome Measures :
  1. ABPM [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. sitting PB [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • men or women, 18 to 75 years
  • hypertension
  • diabetes mellitus type II
  • albuminuria

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00561171

Dr. John Barton
Ballinasloe, Co Galway, Ireland
Sponsors and Collaborators
Speedel Pharma Ltd.
Study Director: Maria Nicolaides, Dr. Speedel Pharma Ltd.

Responsible Party: Rolf Schlosshauer / Expert Clinical Manager, Novartis Pharma AG Identifier: NCT00561171     History of Changes
Other Study ID Numbers: SPP635CRD05
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: November 21, 2008
Last Verified: November 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms