The effect of single tablet of fixed-dose amlodipine and atorvastatin on blood pressure, lipid profile, and oxidative stress of the patients with type 2 diabetes mellitus

The effect of single tablet of fixed-dose amlodipine and atorvastatin on blood pressure, lipid profile, and oxidative stress of the patients with type 2 diabetes mellitus - The effect of single tablet of fixed-dose amlodipine and atorvastatin on blood pressure, lipid profile, and oxidative stress of the patients with type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004924

Enrollment

Registered

2011-01-24

Start date

2010-12-01

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 sigle tablet of fixed dose amlodipin (5 mg) and atorvatatin (10 mg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)patients whose written imformed consent was obtained (2)patients with type 2 diabetes mellitus complicated with hypertension and hyper LDL-cholesterolemia (3)patients who do not achieve the target designated in the Japanese Atherosclerosis society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007.

Exclusion criteria

Exclusion criteria: (1)mild to severe renal dysfunction(CKD stage 3 or more advanced, diabetic nephropathy 3B or more advanced) (2)allergy to amlodipine or atorvastatin (3)liver dysfunciton (acute hepatitis, acute deterioration of chronic hepatitis, liver cirhosis, hepatic cell carcinoma, jaundice) (4)(possible) pregnant woman, breast- feeding woman

Design outcomes

Primary

Measure	Time frame
The blood pressure-lowering effect, the lipid profile-improving effect, and the effect to the MDA-LDL cholestreol of single tablet of fixed dose of amlodipine (5 mg) and atorvastatin (10 mg)	—

Secondary

Measure	Time frame
eGFR, urinary albumin excretion Intima-Media Thickness Pulse Wave Velocity Questionnaire about medication adherance	—

Countries

Japan

Outcome results

None listed

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