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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 20, 2008

Last Updated Date

April 3, 2009

Start Date ^†

September 2008

Current Primary Outcome Measures ^†

Vital signs at every visit [ Time Frame: 10-12.5 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00739973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Vital signs at every visit [ Time Frame: 10-12.5 weeks ] [ Designated as safety issue: No ]
Adverse events at every visit [ Time Frame: 10-12.5 weeks ] [ Designated as safety issue: Yes ]
24-hour blood pressure profile of in a subset of patients at Day 1 and Day 56 (end of study) [ Time Frame: Day 1 and Day 56 ] [ Designated as safety issue: No ]
Biomarker assessments (PRA, PRC) at Day 1 and Day 56 in subset of patients. [ Time Frame: Day 1 and Day 56 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

An 8-Week Double-Blind, Multicenter, Randomized, Multifactorial, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Amlodipine in Patients With Essential Hypertension

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Condition ^†

Hypertension

Intervention ^†

Drug: Aliskiren
Drug: Amlodipine
Drug: Aliskiren/amlodipine
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Aliskiren 150 mg
Experimental: Aliskiren 300 mg
Experimental: Amlodipine 5mg
Experimental: Amlodipine 10 mg
Experimental: Aliskiren/amlodipine 150/5 mg
Experimental: Aliskiren/amlodipine 150/10 mg
Experimental: Aliskiren/amlodipine 300/5 mg
Experimental: Aliskiren/amlodipine 300/10 mg
Experimental: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

1611

Completion Date

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis

862-778-8300

Location Countries ^†

United States, Argentina, Australia, Canada, Colombia, Denmark, Dominican Republic, Finland, Greece, Italy, Mexico, Panama, Peru, Romania, Russian Federation, South Africa, Spain, Sweden, Taiwan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739973

Responsible Party

External Affairs, Novartis

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.