Peripheral Edema Resolution evaluated in patients switched from amlodipine to Levamlodipine (PERLA)

Conditions

Patients with moderate or severe oedema on a long-term treatment with amlodipine

Brief summary

• Change from baseline to end of Period 2 visit of AFV by the water displacement method.

Detailed description

Efficasy: • Change from baseline to end of Period 1 and 3 visit of AFV by the water displacement., Efficasy: • Change from baseline to end of Period 1 (2, 3) visit of the ankle circumference by figure-of-eight method., Efficasy: • Semiquantitative edema scoring in both feet by the investigator at each visit., Efficasy: • Patient reported questionnaire., Additional endpoints: • Number of IMP taken and reported in patient’s diary., Additional endpoints: • Total number (count) of returned IMP., Safety: • Vital signs (SBP, DBP, heart rate, body temperature), and physical examination at each trial visit, Safety: • Incidence of AEs during the entire trial, Safety: • Laboratory examination (on screening visit)

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGS-Amlodipine TAB (VAM) 1.25 mg

DRUGAmlodipine 2.5 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Change from baseline to end of Period 2 visit of AFV by the water displacement method.	—

Secondary

Measure	Time frame
Efficasy: • Change from baseline to end of Period 1 and 3 visit of AFV by the water displacement., Efficasy: • Change from baseline to end of Period 1 (2, 3) visit of the ankle circumference by figure-of-eight method., Efficasy: • Semiquantitative edema scoring in both feet by the investigator at each visit., Efficasy: • Patient reported questionnaire., Additional endpoints: • Number of IMP taken and reported in patient’s diary., Additional endpoints: • Total number (count) of returned IMP., Safety: • Vital signs (SBP, DBP, heart rate, body temperature), and physical examination at each trial visit, Safety: • Incidence of AEs during the entire trial, Safety: • Laboratory examination (on screening visit)	—

Measure

Time frame

Efficasy: • Change from baseline to end of Period 1 and 3 visit of AFV by the water displacement., Efficasy: • Change from baseline to end of Period 1 (2, 3) visit of the ankle circumference by figure-of-eight method., Efficasy: • Semiquantitative edema scoring in both feet by the investigator at each visit., Efficasy: • Patient reported questionnaire., Additional endpoints: • Number of IMP taken and reported in patient’s diary., Additional endpoints: • Total number (count) of returned IMP., Safety: • Vital signs (SBP, DBP, heart rate, body temperature), and physical examination at each trial visit, Safety: • Incidence of AEs during the entire trial, Safety: • Laboratory examination (on screening visit)

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Countries

Czechia

Outcome results

None listed