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

Phase 2

Completed

• Conditions: Hypertension; Type II Diabetes Mellitus
• Interventions: Drug: SPP635

• Registration Number: NCT00561171
• Lead Sponsor: Speedel Pharma Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-20
• Last Update Posted: 2008-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SPP635	high dose
2	SPP635	lower dose

Primary Outcome Measures

Name	Time	Method
ABPM	28 days

Secondary Outcome Measures

Name	Time	Method
sitting PB	28 days

Trial Locations

Locations (1)

Dr. John Barton; 🇮🇪 Ballinasloe, Co Galway, Ireland