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Effectiveness of Switch to Combination Drug on Adherence among Patients with Dyslipidemia and Hypertension

Effectiveness of Switch to Combination Drug on Adherence among Patients with Dyslipidemia and Hypertension - ESCAPADE trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010824
Enrollment
120
Registered
2013-06-01
Start date
2013-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Dyslipidemia and Hypertension

Interventions

Once daily intake of 1 tablet of combination drug of atorvastatin 10mg and amlodipine 5mg on the morning Once daily intake of each 1 tablet of atorvastatin 10mg and amlodipine 5mg on the morning

Sponsors

Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with dyslipidemia and hypertension who take both 10mg of atorvastatin and 5mg of amlodipine

Exclusion criteria

Exclusion criteria: (1) Patients who have a history of stroke or AMI within 3 months (2) Patients with extremely unstable dyslipidemia or hypertension (3) Patients who are joining (or have joined within 3 months) other clinical trials (4) Patients who are taking drugs for dyslipidemia other than atorvastatin (5) Patients whose serum Triglyceride value exceeds 400 mg/dL (6) Patients with familial hyperlipidemia (7) Patients with secondary hyperlipidemia (8) Patients who are taking steroids (9) Patients who are suspected to have drug-induced muscle injury (10) Patients who have, suspected to have, or have a history of elective surgical therapy of malignancies within 3 years. (11) Patients whose serum CK value exceeds threefold of the upper normal limit (12) Patients who have contraindication to the statins or calcium-channel blockers, especially due to hypersensitivity or serious liver damage (13) Patients who are (suspected to be) pregnant (14) Patients who are considered unsuitable for the study by the responsible doctor for some reasonable causes.

Design outcomes

Primary

MeasureTime frame
the difference of the serum LDL Cholesterol value between groups

Secondary

MeasureTime frame
(1) Rate and amount of change in serum LDL-Cho value (2) Quantitative analysis of drug adherence using Japanese edition of MMAS-8 questionnaire (3) Rate and amount of change among other lipid profiles such as HDL-Cho, T-Cho, and TG (4) Rate of achievement in the treatment goal according to the Japanese guideline for the prevention of atherosclerosis (5) Rate and amount of change in office blood pressures (6) Subanalyses as to sex, age, BMI, serum LDL value on baseline, number of tablets taken, and use of narcotics (7) Effect of the change in pattern to take drugs on serum lipid profiles

Countries

Japan

Contacts

Public ContactSho Okada

Chiba University Graduate School of Medicine Department of Cardiovascular Medicine

shookada_circ@chiba-u.jp0432262555

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026