A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk (TOGETHER)

Viatris

Status and phase: Completed; Phase 4

Conditions: Hypertension; Dyslipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412113

A3841045

Details and patient eligibility

About

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

Enrollment: 245 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Exclusion criteria

• Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
• Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
• Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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245 participants in 4 patient groups

Norvasc 5 mg

Active Comparator group

Description:

Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.

Treatment:

Drug: Amlodipine besylate

Drug: Amlodipine besylate

Caduet 10/20mg

Experimental group

Description:

Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.

Treatment:

Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Norvasc 10 mg

Active Comparator group

Description:

Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.

Treatment:

Drug: Amlodipine besylate

Drug: Amlodipine besylate

Caduet 5/20mg

Experimental group

Description:

Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .

Treatment:

Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Drug: Amlodipine besylate/atorvastatin calcium single pill combination