Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors (CRUCIAL)

Viatris

Status and phase: Completed; Phase 4

Conditions: Hypertension; Hypercholesterolemia

Treatments: Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407537

A3841047

Details and patient eligibility

About

To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.

Enrollment: 1,531 patients

Sex: All

Ages: 35 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)

Exclusion criteria

• Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
• Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,531 participants in 1 patient group

Caduet

Experimental group

Description:

Open label caduet added to usual care regimen followed by investigators.

Treatment:

Drug: Amlodipine besylate/atorvastatin calcium single pill combination