Hypertension
Conditions
Brief summary
In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be studied.
Interventions
DRUGLacidipine
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Fulfillment of entry criteria for the preceding yearly study * Male or female patients aged between 20 and 85 years * Known history of mild to moderate essential hypertension requiring drug treatment, WHO grade I to II * Controlled blood pressure (RR diastolic ≤ 90 mm Hg or 91 - 95 mm Hg and concurrent reduction in blood pressure of at least 10 mm compared to baseline level) during treatment with lacidipine at a dose of 2 - 6 mg once a day * Final visit of the previous yearly study (Visit 4) completed as scheduled * Informed consent to participate in the follow-up study
Exclusion criteria
* Violation of entry/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with rare adverse drug reactions | up to 24 months |
| Change in alkaline phosphatase (AP) | up to 24 months |
| Change in serum glutamic - pyruvic transaminase (SGPT) | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum glutamic - oxaloacetic transaminase (SGOT) | up to 24 months |
| Changes in gamma glutamyl transferase (gamma-GT) | up to 24 month |
| Number of patients with abnormal changes in laboratory parameters | up to 24 months |
| Changes in systolic and diastolic blood pressure | up to 24 months |
Outcome results
None listed