Efficacy and Safety of Lacidipine in Chronic Stable Angina

Phase 2

Completed

• Conditions: Angina Pectoris
• Interventions: Drug: Lacidipine, medium dose; Drug: Lacidipine, high dose; Drug: Lacidipine, low dose; Drug: Placebo

• Registration Number: NCT02232607
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Primary Completion: 1999-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-04
• Last Update Submitted: 2014-09-04
• Study First Posted: 2014-09-05
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lacidipine, low dose	Placebo	-
Lacidipine, medium dose	Lacidipine, medium dose	-
Lacidipine, medium dose	Placebo	-
Lacidipine, high dose	Lacidipine, high dose	-
Placebo	Placebo	-
Lacidipine, low dose	Lacidipine, low dose	-

Primary Outcome Measures

Name	Time	Method
Change in total treadmill exercise duration	Baseline, week 6

Secondary Outcome Measures

Name	Time	Method
Consumption of short-acting nitrates	up to 6 weeks
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