NCT02232607

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1999

Completed
15.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

September 4, 2014

Last Update Submit

September 4, 2014

Conditions

Angina Pectoris

Outcome Measures

Primary Outcomes (1)

  • Change in total treadmill exercise duration

    Baseline, week 6

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (4)

Lacidipine, low dose

EXPERIMENTAL
Drug: Lacidipine, low doseDrug: Placebo

Lacidipine, medium dose

EXPERIMENTAL
Drug: Lacidipine, medium doseDrug: Placebo

Lacidipine, high dose

EXPERIMENTAL
Drug: Lacidipine, high dose

Placebo

ACTIVE COMPARATOR
Drug: Placebo

Interventions

Lacidipine, low doseDRUG
Lacidipine, low dose
Lacidipine, medium doseDRUG
Lacidipine, medium dose
Lacidipine, high doseDRUG
Lacidipine, high dose
PlaceboDRUG
Lacidipine, low doseLacidipine, medium dosePlacebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Angina Pectoris

Interventions

lacidipine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 5, 2014

Study Start

April 1, 1998

Primary Completion

June 1, 1999

Last Updated

September 5, 2014

Record last verified: 2014-09