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Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Moderate to Severe Hypertension

Intervention: Aliskiren/amlodipine 300/10 mg tablet (Drug); Amlodipine 10 mg capsule (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

Summary

This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.

Clinical Details

Official title: An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Sitting Systolic Blood Pressure (msSBP)

Secondary outcome:

Mean Sitting Diastolic Blood Pressure (msDBP)

Systolic Blood Pressure Response

Diastolic Blood Pressure Response

Blood Pressure Control

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients ≥ 18 years of age

- Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160

mmHg and < 200 mmHg at Visit 2 Exclusion Criteria:

- Mild to moderate hypertension

- Pregnant or nursing (lactating) women

- Women of child-bearing potential

- Previous or current diagnosis of heart failure New York Heart Association(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 hypertensive encephalopathy or cerebrovascular accident, or history of

transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention

- Patients on a combination of 3 or more antihypertensive medications

Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Investigative Site, Berlin, Germany

Investigative Site, Manilla, Philippines

Investigative Site, Bucharest, Romania

Investigative Site, Moscow, Russian Federation

Investigative Site, Singapore, Singapore

Investigative Site, Madrid, Spain

Additional Information

Starting date: January 2009
Last updated: July 5, 2011

Page last updated: August 23, 2015

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