Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

Viatris

Status and phase

Completed

Phase 4

Conditions

Hypertension

Hypercholesterolemia

Angina Pectoris

Treatments

Drug: Caduet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01190007

A3841064

Details and patient eligibility

About

The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.

Enrollment

159 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3):
(1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0)
(2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
(3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2
Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3):
(1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris
(2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
(3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2

Exclusion criteria

Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg.
Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated