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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.
Information provided by:
Speedel Pharma Ltd. Identifier:
First received: November 19, 2007
Last updated: November 20, 2008
Last verified: November 2008

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: 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

Further study details as provided by Speedel Pharma Ltd.:

Primary Outcome Measures:
  • ABPM [ Time Frame: 28 days ]

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

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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00561171

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

Responsible Party: Rolf Schlosshauer / Expert Clinical Manager, Novartis Pharma AG Identifier: NCT00561171     History of Changes
Other Study ID Numbers: SPP635CRD05
Study First Received: November 19, 2007
Last Updated: November 20, 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms processed this record on August 18, 2017