Efficacy and Safety of Lacidipine in Chronic Stable Angina

A Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Lacidipine in Chronic Stable Angina.

The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg decreased the symptoms of angina, compared to placebo in patients with chronic stable angina

Study Overview

• Status: Completed
• Conditions: Angina Pectoris
• Intervention / Treatment: Drug: Placebo; Drug: Lacidipine, low dose; Drug: Lacidipine, medium dose; Drug: Lacidipine, high dose

• Study Type: Interventional
• Enrollment (Actual): 283
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 to 80 years
• History of stable, exertional angina pectoris (Canadian Cardiovascular Society functional class II to III) for at least 3 months duration prior to enrolment in the study
• Patients not currently receiving treatment with antianginal medication (other than short-acting nitrates)
• Between visits 2 and 3 two treadmill exercise tests, demonstrating ≥ 0.1 mV of horizontal or down sloping ST-segment depression, must be carried out. The difference in symptom-limited exercise duration between these two tests must not exceed 20%
• Total treadmill exercise duration > 3 minutes (i.e. stage 2 or above on a standard Bruce protocol)
• Coronary artery disease, preferably (not mandatory) documented by a history of proven myocardial infarction and/or coronary angiography indicating ≥ 50% reduction in luminal diameter of one or more coronary arteries or their primary branches

Exclusion Criteria:

• Myocardial infarction within 3 months prior to enrolment in the study
• Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within 6 months
• Other types of angina (variant, unstable)
• Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg)
• Resting heart rate < 50 bpm or > 100 bpm
• Significant valvular heart disease
• Heart failure New York Heart Association Class III or IV
• Chronic obstructive pulmonary disease and/or asthma with clinical symptoms requiring regular medication
• Significant arrhythmia (since this may interfere with the interpretation of the electrocardiogram) including Wolff Parkinson-White syndrome, atrial fibrillation, atrial flutter, sick sinus syndrome, significant Atrio-Ventricular heart block, intraventricular conduction defect (QRS > 0.12 seconds) ventricular pre-excitation, bundle branch block, the presence of a pace-maker, the presence of an implanted automatic defibrillator, uncorrected hypokalaemia (potassium < 3.5 mmol/litre)
• Insulin dependent diabetes mellitus
• Significant liver disease (Aspartate Aminotransferase or Alanine Aminotransferase > twice the upper limit of reference range)
• Significant renal disease (creatinine > 1.5 x upper limit of reference range)
• Any clinical condition which in the opinion of the investigator, would preclude the safe fulfilment of the protocol and the safe administration of trial medication
• Inability to perform repeated exercise testing due to extra-cardiac reasons
• Concomitant treatment with any other anti-anginal medication, whether or not prescribed for this indication (e.g. calcium channel blockers, β-blockers or long-acting nitrates)
• Concomitant treatment with anti-arrhythmic medication, digitalis or tricyclic anti-depressants or other agents known to affect ST-segment morphology
• Known hypersensitivity to any of the components of the investigational drug
• Pregnant or nursing women or women of child bearing potential
• Participation in any other clinical trial within 2 months of enrolment
• History of drug or alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo	Drug: Placebo
Experimental: Lacidipine, low dose	Drug: Placebo; Drug: Lacidipine, low dose
Experimental: Lacidipine, medium dose	Drug: Placebo; Drug: Lacidipine, medium dose
Experimental: Lacidipine, high dose	Drug: Lacidipine, high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total treadmill exercise duration	Baseline, week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	up to 6 weeks
Change in time to ST segment depression (≥ 0.1 mV)	up to 6 weeks
Treadmill exercise time to first report of anginal pain	week 6
Reason for termination of treadmill exercise test	up to 6 weeks
Frequency/severity of anginal attacks	up to 6 weeks
Consumption of short-acting nitrates	up to 6 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1998
• Primary Completion (Actual): June 1, 1999

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimate): September 5, 2014

Study Record Updates

• Last Update Posted (Estimate): September 5, 2014
• Last Update Submitted That Met QC Criteria: September 4, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Lacidipine
• Other Study ID Numbers: 231.339