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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.
Sponsor:
Information provided by:
Speedel Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT00561171
First received: November 19, 2007
Last updated: November 20, 2008
Last verified: November 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1
high dose
 Drug: SPP635
oral once daily
Experimental: 2
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
Dr. John Barton
Ballinasloe, Co Galway, Ireland
Sponsors and Collaborators
Speedel Pharma Ltd.
Investigators
Study Director: Maria Nicolaides, Dr. Speedel Pharma Ltd.
  More Information

No publications provided

Responsible Party: Rolf Schlosshauer / Expert Clinical Manager, Novartis Pharma AG
ClinicalTrials.gov Identifier: NCT00561171     History of Changes
Other Study ID Numbers: SPP635CRD05
Study First Received: November 19, 2007
Last Updated: November 20, 2008
Health Authority: Ireland: Irish Medicines Board
Hungary: National Institute of Pharmacy

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

ClinicalTrials.gov processed this record on May 19, 2013