Trial Condition(s):
Hypertension
High Dose BAYA1040_Nifedipine: a long term combination study
Bayer Identifier:
14024
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.
Inclusion Criteria
- 20 years or older - Japanese male or female - Outpatient with essential hypertension - Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study
Exclusion Criteria
- Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more - Patients with secondary hypertension or hypertensive emergency
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Sugiura Iin Kawaguchi, Japan, 332-0012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sagamino Central Hospital Ebina, Japan, 243-0401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oda Clinic Shinjuku, Japan, 169-0072 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yamamoto Clinic Sagamihara, Japan, 252-0311 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multicenter, open label, long term study of oral BAYA1040_CR 80 mg (40 mg bid) in combination with other antihypertensives for 52 weeks in patients with essential hypertension
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Efficacy changes measured by sitting diastolic blood pressure (DBP)Timeframe: Up to 52 weeks
Secondary Outcome
- Efficacy changes measured by sitting systolic blood pressure (SBP)Timeframe: Up to 52 weeks
- Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelinesTimeframe: Up to 52 weeks
- Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBPTimeframe: Up to 52 weeks
- Safety variablesAdverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.Timeframe: Up to 30 days after the last dose of study drug
Additional Information
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