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Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
This study has been completed.
Study NCT00561171   Information provided by Speedel Pharma Ltd.
First Received: November 19, 2007   Last Updated: November 20, 2008   History of Changes

November 19, 2007
November 20, 2008
November 2007
September 2008   (final data collection date for primary outcome measure)
ABPM [ Time Frame: 28 days ] [ Designated as safety issue: No ]
ABPM [ Time Frame: 28 days ]
Complete list of historical versions of study NCT00561171 on ClinicalTrials.gov Archive Site
sitting PB [ Time Frame: 28 days ] [ Designated as safety issue: No ]
sitting PB [ Time Frame: 28 days ]
 
Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
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

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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment
  • Hypertension
  • Type II Diabetes Mellitus
Drug: SPP635
  • Experimental: high dose
  • Experimental: lower dose
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT00561171
Rolf Schlosshauer / Expert Clinical Manager, Novartis Pharma AG
SPP635CRD05
Speedel Pharma Ltd.
 
Study Director: Maria Nicolaides, Dr. Speedel Pharma Ltd.
Speedel Pharma Ltd.
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP