Efficacy and Safety of Lacidipine in Chronic Stable Angina

Angina Pectoris Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232607
• Other study ID #: 231.339
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2014
• Last updated: September 4, 2014
• Start date: April 1998

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyCroatia: Agency for Medicinal Product and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. primary completion date: June 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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, ß-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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable

Intervention

Drug:
• Lacidipine, low dose

• Lacidipine, medium dose

• Lacidipine, high dose

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total treadmill exercise duration		Baseline, week 6	No
Secondary	Change in time to ST segment depression (= 0.1 mV)		up to 6 weeks	No
Secondary	Treadmill exercise time to first report of anginal pain		week 6	No
Secondary	Reason for termination of treadmill exercise test		up to 6 weeks	No
Secondary	Frequency/severity of anginal attacks		up to 6 weeks	No
Secondary	Consumption of short-acting nitrates		up to 6 weeks	No
Secondary	Number of patients with adverse events		up to 6 weeks	No

External Links

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