Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension

NCT02177331 | Completed Phase 3

• 1 other identifier: 231.215
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in serum glutamic - oxaloacetic transaminase (SGOT)

  up to 24 months

• Number of patients with abnormal changes in laboratory parameters

  up to 24 months

• Changes in systolic and diastolic blood pressure

  up to 24 months

• Changes in gamma glutamyl transferase (gamma-GT)

  up to 24 month

Study Arms (1)

Lacidipine

EXPERIMENTAL

Drug: Lacidipine

Interventions

Lacidipine DRUG

Lacidipine

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

lacidipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 1995
• Primary Completion: January 1, 1998
• Last Updated: July 14, 2014

Record last verified: 2014-07