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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561171
• Other study ID #: SPP635CRD05
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2007
• Last updated: November 20, 2008
• Start date: November 2007
• Est. completion date: September 2008

Study information

• Verified date: November 2008
• Source: Speedel Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines BoardHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus, Type 2
• Hypertension
• Type II Diabetes Mellitus

Intervention

Drug:
• SPP635
oral once daily

Locations

Country	Name	City	State
Ireland	Dr. John Barton	Ballinasloe	Co Galway

Sponsors (1)

Lead Sponsor	Collaborator
Speedel Pharma Ltd.

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABPM		28 days	No
Secondary	sitting PB		28 days	No