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Completed

NCT Number: NCT00561171

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type II Diabetes Mellitus Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. John Barton

Ballinasloe, Co Galway, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPP635

Drug

oral once daily

Primary outcomes

  1. ABPM

    Time frame: 28 days

Secondary outcomes

  1. sitting PB

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Speedel Pharma Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 20, 2007
Registry last updated
Nov 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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