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A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-week Study to Investigate the Safety and Efficacy of Oral SPP635 450 mg Once Daily in Patients With Mild to Moderate Hypertension

A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-week Study to Investigate the Safety and Efficacy of Oral SPP635 450 mg Once Daily in Patients With Mild to Moderate Hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004176-13-DE
Enrollment
Unknown
Registered
2007-01-31
Start date
2006-10-11
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild to moderate hypertension

Interventions

Product Name: SPP635 Product Code: SPP635 Pharmaceutical Form: Capsule, hard CAS Number: pending Current Sponsor code: SPP635 Other descriptive name: renin inhibitor Concentration unit: mg milligram(s

Sponsors

Speedel Pharma Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with mild to moderate hypertension with blood pressures between 140 and 179 mmHg systolic, and 109 mmHg diastolic blood pressure (office blood pressure) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women of childbearing potential pregnant and lactating women any current or past heart disease any history of kidney failure any history of diabetes mellitus HbA1c > 6%

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate if SPP635 lowers blood pressure;Secondary Objective: To evaluate the safety of SPP635, To evaluate if SPP635 has an effect on albuminuria;Primary end point(s): The primary endpoint is the change of blood pressure after 4-weeks treatment from baseline.—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026