Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-Severe Hypertension - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00765674

Purpose

Evaluate the efficacy (blood pressure lowering effect) and safety of Aliskiren/Amlodipine/Hydrochlorothiazide in patients with moderate to severe Hypertension.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren 150/Amlodipine 5 mg, 300/10 mg Drug: Aliskiren 150/Hydrochlorothiazide 12.5 mg, 300/25 mg Drug: Amlodipine 150/Hydrochlorothiazide 12.5 mg, 10/25 mg Drug: Aliskiren 150/Amlodipine 5/Hydrochlorothiazide 12.5 mg, 300/10/25 mg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8 Week, Double-blind, Randomized, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren /Amlodipine / HCTZ in Patients With Moderate to Severe Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Vital signs at every visit [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Vital signs at every visit [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Adverse events at every visit [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
24-hour ambulatory blood pressure measurement of a subset of patients at Day 1 and Day 56 (end of study) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Changes in biomarker assessments (PRA, PRC) at Day 1 and Day 56 in subset of patients [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	1160
Study Start Date:	September 2008
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren 150/Amlodipine 5 mg, 300/10 mg	Drug: Aliskiren 150/Amlodipine 5 mg, 300/10 mg Aliskiren 150/Amlodipine 5 mg, 300/10 mg
2: Experimental Aliskiren 150/Hydrochlorothiazide 12.5 mg, 300/25 mg	Drug: Aliskiren 150/Hydrochlorothiazide 12.5 mg, 300/25 mg Aliskiren 150/Hydrochlorothiazide 12.5 mg, 300/25 mg
3: Experimental Amlodipine 150/Hydrochlorothiazide 12.5 mg, 10/25 mg	Drug: Amlodipine 150/Hydrochlorothiazide 12.5 mg, 10/25 mg Amlodipine 150/Hydrochlorothiazide 12.5 mg, 10/25 mg
4: Experimental Aliskiren 150/Amlodipine 5/Hydrochlorothiazide 12.5 mg, 300/10/25 mg	Drug: Aliskiren 150/Amlodipine 5/Hydrochlorothiazide 12.5 mg, 300/10/25 mg Aliskiren 150/Amlodipine 5/Hydrochlorothiazide 12.5 mg, 300/10/25 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female
18 years of age or older
Diagnosis of moderate to severe hypertension

Exclusion Criteria:

Continued use of anti-hypertensive medicines or use of 4 or more hypertensive medicines at study start
Extremely elevated (defined) blood pressure at any point during the study
Pregnant or lactating women
Pre-menopausal women not taking accepted form of birth control
History or evidence of secondary form of hypertension
History of cardiovascular conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765674

Locations

United States, Colorado
Investigative Site
Denver, Colorado, United States
Australia
Investigative Site
Sydney, Australia
Canada
Investigative Site
Ottawa, Canada
Denmark
Investigative Site
Copenhagen, Denmark
Germany
Investigative Site
Berlin, Germany
Israel
Investigative Site
Jerusalem, Israel
Italy
Investigative Site
Rome, Italy
Latvia
Investigative Site
Riga, Latvia
Lithuania
Investigative Site
Vilnius, Lithuania
Romania
Investigative Site
Bucharest, Romania
Sweden
Investigative Site
Stockholm, Sweden
Turkey
Investigative Site
Ankara, Turkey

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSAH100A2302
Study First Received:	October 2, 2008
Last Updated:	October 16, 2009
ClinicalTrials.gov Identifier:	NCT00765674 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada; Italy: National Institute of Health; Sweden: Medical Products Agency; Romania: National Medicines Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; United States: Food and Drug Administration; Denmark: Danish Medicines Agency; Israel: Ministry of Health; Lithuania: State Medicine Control Agency - Ministry of Health; Zanzibar: Ministry of Health and Social Welfare; Latvia: State Agency of Medicines

Keywords provided by Novartis:

Aliskiren, antihypertensive, Hypertension, Renin Inhibitor
Moderate-Severe Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010