A randomized, placebo-controlled, double-blind, six-arm, dose escalation, multi-center study to evaluate the efficacy and safety of SLV306: 150, 300, 600 mg once daily, 150-300 mg twice daily and amlodipine 5-10 mg once daily in subjects with hypertensio

Phase 1

• Conditions: Hypertension

• Registration Number: EUCTR2004-000305-21-GB
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-23
• Study Completion: 2006-09-05
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 522

Inclusion Criteria

Inclusion criteria at screening:
1.Male or female patients =18 with hypertension. Females must be without childbearing potential.
2.Documented history of mild to moderate hypertension.
3.Sitting office diastolic blood pressure = 109 mmHg.

Inclusion criteria at baseline:
Sitting office diastolic blood pressure = 90 mmHg and = 109 mmHg
Sitting office systolic blood pressure = 140 mmHg and = 179 mmHg
Mean 24-ABPM day-time diastolic blood pressure = 85 mmHg
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

1.Any woman of child-bearing potential who is pregnant, lactating, or not using a medically approved contraceptive method for at least 3 months prior to Visit 1.
2.Evidence of any respiratory, urogenital, gastrointestinal / hepatic, hematological /
immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic / connective tissue, musculoskeletal, metabolic / nutritional, endocrine, neurologic / psychiatric diseases, allergy, major surgery or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which might limit participation in or completion of the study.
3.Concomitant use of other investigational drugs
4.Severe allergy or any history of severe abnormal drug reaction to amlodipine
5.Previous participation in any study with SLV306, including previous participation in this study.
6.Treatment for malignancy, except for basal cell carcinoma of the skin, within 12 months prior to Visit 1
7.Significant hepatic disease (two times the upper limit of normal ALT and AST) as measured at Visit 1.
8.Significantly reduced renal function (creatinine = 200 µmol/L) as measured at Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified