Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients (ALIAS)

Novartis

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: Aliskiren; Drug: Ramipril; Drug: Matching placebo to Aliskiren; Drug: Matching placebo to Ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT01042392

CSPP100AFR01

2009-011296-80 (EudraCT Number)

Details and patient eligibility

About

This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.

Enrollment: 506 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients > 18 years

• Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods

• Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.

• BP thresholds at visit 1:

  • For patients previously treated and uncontrolled: 140≤ office SBP<180 mmHg
  • For patients previously treated, controlled but intolerant: office SBP≥130 mmHg

• BP thresholds at visit 2 (for all patients):

  • 160≤office SBP<180 mmHg AND
  • 155≤home SBP<175 mmHg (3-day period of home blood pressure monitoring just before randomization)

Exclusion criteria

• Women of child-bearing potential not using any effective methods of contraception
• Severe hypertension (office BP ≥ 180/110 mmHg)
• Impossibility to stop abruptly previous antihypertensive treatments at visit 1
• Patients previously untreated or patients treated with two or three antihypertensive medications
• History or evidence of a secondary form of hypertension
• History of hypersensitivity to ACEi or renin inhibitors
• History of heart failure, stroke or coronary heart disease
• Serum potassium ≥ 5.2 mmol/l

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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506 participants in 4 patient groups, including a placebo group

Ramipril

Active Comparator group

Description:

In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in. In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4. In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Treatment:

Drug: Ramipril

Drug: Matching placebo to Aliskiren

Aliskiren

Experimental group

Description:

In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in. In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4. In period III (double-blind withdrawal ): At visit 4, part of the patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Treatment:

Drug: Matching placebo to Ramipril

Drug: Aliskiren

Placebo to Ramipril

Placebo Comparator group

Description:

In period III (double-blind withdrawal ): At visit 4, part of patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Treatment:

Drug: Matching placebo to Ramipril

Placebo to Aliskiren

Placebo Comparator group

Description:

In period III (double-blind withdrawal ): At visit 4, part of the patients from Aliskiren arm received placebo to Aliskiren for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Treatment:

Drug: Matching placebo to Aliskiren