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 hypertension.
- Conditions
- Hypertension
- Registration Number
- EUCTR2004-000305-21-LT
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 522
Inclusion criteria as screening:
1. Male or female patients = 18 with hypertension. Females of child bearing potential must use a medically approved contraceptive method for at least 3 months prior to Visit 1.
2. Documented history of mild to moderate hypertension.
3. Sitting office diastolic blood pressure = 109mm Hg.
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 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
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 / pyschiatric disease, 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 or received any investigational agent within the previous one calendar month prior to Visit 1.
4. Severe allergy or any history of severe abnormal drug reaction to amlodipine.
5. Treatment for malignancy, except for basal cell carcinoma of the skin, within 12 months prior to Visit 1.
6. Previous participation in any study with SLV306, including previous participation in this study.
7. Subjects related to the investigator in any way (family relation, practice workers etc.).
8. Significant hepatic disease (two times the upper limit of normal ALT and AST) as measured at Visit 1.
9. 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method