NCT Number: NCT02177331
Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension
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.
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Conditions
Age range
20 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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/exclusion criteria on enrolment in the preceding yearly study
- Occurrence of the following exclusion criteria in the intervening period:
- Pregnancy, lactation, possibility of conception without the use of a scientifically recognised method of contraception
- Secondary form of hypertension
- Consumptive illness
- Clinically manifest concomitant cardiovascular illness, e.g.: aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy or any other condition hindering left ventricular outflow, aortic isthmus stenosis, severe (NYHA Class III or higher) or decompensated heart failure, clinically relevant hypo- or hyperkinetic cardiac arrhythmia
- Myocardial infarction or cerebrovascular accident within the 6 months prior to the start of the follow-up study
- Hypersensitivity to dihydropyridines
- Concomitant long-term treatment (> 3 weeks) with antihypertensive substances not envisaged in the protocol (exception: short-acting nitrates), sedatives, tricyclic antidepressants
- Suspected alcohol, narcotic or drug abuse
Treatment and study plan
Primary outcomes
-
Number of patients with rare adverse drug reactions
Time frame: up to 24 months
-
Change in alkaline phosphatase (AP)
Time frame: up to 24 months
-
Change in serum glutamic - pyruvic transaminase (SGPT)
Time frame: up to 24 months
Secondary outcomes
-
Change in serum glutamic - oxaloacetic transaminase (SGOT)
Time frame: up to 24 months
-
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 24 months
-
Changes in systolic and diastolic blood pressure
Time frame: up to 24 months
-
Changes in gamma glutamyl transferase (gamma-GT)
Time frame: up to 24 month
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Lacidipine in Medical Practice: Incidence of Rare Adverse Drug Reactions During Long-term Treatment. 3rd Follow-up Study - Long-term Use in the 4th and 5th Year Treatment Years
Important dates
- Study start
- 1995
- Primary completion
- 1998
- First posted
- Jun 27, 2014
- Registry last updated
- Jul 14, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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