Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Aliskiren 300 mg tablet; Drug: Aliskiren/amlodipine 300/10 mg tablet; Drug: Aliskiren/amlodipine 150/10 mg tablet; Drug: Amlodipine 5 mg capsule; Drug: Aliskiren/amlodipine 150/5 mg tablet; Drug: Aliskiren/amlodipine 300/5 mg tablet; Drug: Amlodipine 10 mg capsule; Drug: Aliskiren 150 mg tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739973

CSPA100A2305

Details and patient eligibility

About

Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.

Enrollment: 2,694 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• msDBP ≥ 90 mmHg and < 110 mmHg at the visit prior to Visit 3 (Visit 2 or optional Visit 201)
• msDBP ≥ 95 mmHg and < 110 mmHg at Visit 3 (Day 1 / randomization).
• All patients must have an absolute difference of ≤ 10 mmHg in their msDBP during the last 2 visits of the single-blind run-in period (Visit 2 and 3 or Visits 201 and 3).

Exclusion criteria

• Severe hypertension
• Pregnant or nursing (lactating) women
• Women of child-bearing potential
• Previous or current diagnosis of heart failure (NYHA Class II-IV).
• Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
• Uncontrolled Type 1 or Type 2 diabetes mellitus
• Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
• History of malignancy within 5 years
• History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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2,694 participants in 9 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 5 of the 5 pills taken were placebos.

Treatment:

Drug: Placebo

Aliskiren 150 mg tablet

Experimental group

Description:

Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Treatment:

Drug: Placebo

Drug: Aliskiren 150 mg tablet

Aliskiren 300 mg tablet

Experimental group

Description:

Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Treatment:

Drug: Aliskiren 300 mg tablet

Drug: Placebo

Amlodipine 5 mg capsule

Experimental group

Description:

Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Treatment:

Drug: Amlodipine 5 mg capsule

Drug: Placebo

Amlodipine 10 mg capsule

Experimental group

Description:

Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg

Treatment:

Drug: Placebo

Drug: Amlodipine 10 mg capsule

Aliskiren/amlodipine 150/5 mg tablet

Experimental group

Description:

Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Treatment:

Drug: Placebo

Drug: Aliskiren/amlodipine 150/5 mg tablet

Aliskiren/amlodipine 150/10 mg tablet

Experimental group

Description:

150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Treatment:

Drug: Aliskiren/amlodipine 150/10 mg tablet

Drug: Placebo

Aliskiren/amlodipine 300/5 mg tablet

Experimental group

Description:

Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Treatment:

Drug: Aliskiren/amlodipine 300/5 mg tablet

Drug: Placebo

Aliskiren/amlodipine 300/10 mg tablet

Experimental group

Description:

300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Treatment:

Drug: Aliskiren/amlodipine 300/10 mg tablet

Drug: Placebo