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

Sponsored by:	Speedel Pharma Ltd.
Information provided by:	Speedel Pharma Ltd.
ClinicalTrials.gov Identifier:	NCT00561171

Purpose

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

MedlinePlus related topics: Diabetes High Blood Pressure

U.S. FDA Resources

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

Further study details as provided by Speedel Pharma Ltd.:

Primary Outcome Measures:

ABPM [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

sitting PB [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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	Drug: SPP635 oral once daily
2: Experimental lower dose	Drug: SPP635 oral once daily

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561171

Locations

Ireland, Co Galway
Dr. John Barton
Ballinasloe, Co Galway, Ireland

Sponsors and Collaborators

Speedel Pharma Ltd.

Investigators

Study Director:

Maria Nicolaides, Dr.

Speedel Pharma Ltd.

More Information

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Urological Manifestations
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009