Effect of Combination tablets with telmisartan and amlodipine in hypertensive patients with metabolic syndrome not controlled by conventional therapy, randomized, open label, multicenter, parallel group study

Effect of Combination tablets with telmisartan and amlodipine in hypertensive patients with metabolic syndrome not controlled by conventional therapy, randomized, open label, multicenter, parallel group study - Effect of Combination tablets with telmisartan and amlodipine in hypertensive patients with metabolic syndrome (Cotalo)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005265

Enrollment

Registered

2011-03-18

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

Hypertension with metabolic syndrome

Interventions

Oral administration of Micamlo combination Tablets AP (telmisartan 40 mg/day + amlodipine 5 mg/day) in the morning Oral administration of Micamlo combination Tablets AP (telmisartan 40 mg/day + amlodi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Ambulant patients, regardless of sex. Age is over 30 years old. Patients with uncontrolled hypertension by amlodipine 5 mg/day complicated with metabolic syndrome. Hypertension; >= SBP 140mmHg and/or >= DBP 90mmHg Metabolic syndrome; waist size >=85cm in male, >= 90cm in female and have one or both symptoms listed below. 1. TG >= 150mg/dL and/or HDL >=40mg/dL 2. FPG >= 110mg/dL

Exclusion criteria

Exclusion criteria: 1) Secondary hypertension 2) Severe hypertension with office systolic blood pressure over 180mmHg and/or diastolic blood pressure over 110mmHg 3) Malignant hypertension 4) Continuous ventricular tachycardia or severe arrythmia (AV block II-III, Af etc) 5) Severe heart failure (NYHA III-IV) 6) Myocardial Infarction, Coronary bypass surgery, and PTCA were performed within 6 months 7) Patients contraindicated for the use of amlodipine, telmisartan 8) Serum creatinine >2.1mg/dL 9) Hypersensitivity with telmisartan and amlodipine 10) Patients who are inadequate to entry this study judged by physicians in charge

Design outcomes

Primary

Measure	Time frame
Changes of 24hr blood pressure on ABPM(24hr, daytime, nocturnal, early morning)	—

Countries

Japan

Contacts

Public ContactMitsuru Ohishi

Osaka University Department of Geriatric Medicine & Nephrology

06-6879-3852

Outcome results

None listed

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