The effect of single tablet of fix-dose amlodipine and atorvastatin on blood pressure, lipid profile, and endothelium dependent relaxation of people with type 2 diabetes mellitus

The effect of single tablet of fix-dose amlodipine and atorvastatin on blood pressure, lipid profile, and endothelium dependent relaxation of people with type 2 diabetes mellitus - The effect of single tablet of fix-dose amlodipine and atorvastatin on blood pressure, lipid profile, and endothelium dependent relaxation of people with type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006063

Enrollment

Registered

2011-07-28

Start date

2011-03-01

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

Type 2 diabetes mellitus hypertension dyslipidemia

Interventions

Administration of single-pill of fixed dose amlodipin (5mg) and atorvatatin (10mg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. people whose written imformed consent was obtained 2. people with type 2 diabetes mellitus complicated with hypertension and dyslipidemia 3. people were treated with amlodipin and any kind of statin except Atrovastatin for 3 months

Exclusion criteria

Exclusion criteria: 1. the onset of ischemic heart disease (IHD) or stroke within 3 months 2. severe renal failure(Cr > 1.5mg/dl) and liver injury (AST and/or ALT > 100IU/dL) 3. pregnancy 4. Severe health problems not suitable for the study

Design outcomes

Primary

Measure	Time frame
the effect of single-pill amlodipin/atrovastatin upon FMD between baseline and after 3 months	—

Secondary

Measure	Time frame
Changes in the following items blood pressure lipid profiles (Total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglyceride, Malondialdehyde-modified low-density lipoprotein) Fasting blood glucose, HbA1c, GA Intima-Media Thickness (IMT) eGFR, urinary albumin excretion Questionnaire about medication adherance Adverse effect	—

Countries

Japan

Outcome results

None listed

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