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Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-Severe Hypertension
This study is currently recruiting participants.
Verified by Novartis, October 2008
Sponsored by: 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
Moderate-Severe 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

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Aliskiren
U.S. FDA Resources
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

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 ]

Estimated Enrollment: 1160
Study Start Date: September 2008
Estimated Primary Completion Date: November 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

Contacts
Contact: Novartis 862-778-8300

Locations
United States, Colorado
Investigative Site Recruiting
Denver, Colorado, United States
Contact: Novartis     862-778-8300        
Australia
Investigative Site Recruiting
Sydney, Australia
Contact: Novartis     862-778-8300        
Canada
Investigative Site Recruiting
Ottawa, Canada
Contact: Novartis     862-778-8300        
Denmark
Investigative Site Recruiting
Copenhagen, Denmark
Contact: Novartis     862-778-8300        
Germany
Investigative Site Recruiting
Berlin, Germany
Contact: Novartis     862-778-8300        
Israel
Investigative Site Recruiting
Jerusalem, Israel
Contact: Novartis     862-778-8300        
Italy
Investigative Site Recruiting
Rome, Italy
Contact: Novartis     862-778-8300        
Latvia
Investigative Site Recruiting
Riga, Latvia
Contact: Novartis     862-778-8300        
Lithuania
Investigative Site Recruiting
Vilnius, Lithuania
Contact: Novartis     862-778-8300        
Romania
Investigative Site Recruiting
Bucharest, Romania
Contact: Novartis     862-778-8300        
South Africa
Investigative Site Recruiting
Pretoria, South Africa
Contact: Novartis     862-778-8300        
Sweden
Investigative Site Recruiting
Stockholm, Sweden
Contact: Novartis     862-778-8300        
Turkey
Investigative Site Recruiting
Ankara, Turkey
Contact: Novartis     862-778-8300        
Sponsors and Collaborators
Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CSAH100A2302
Study First Received: October 2, 2008
Last Updated: October 2, 2008
ClinicalTrials.gov Identifier: NCT00765674  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices;   Canada: Health Products and Food Branch;   Italy: National Institute of Health;   South Africa: Medicines Control Council;   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

Study placed in the following topic categories:
Calcium, Dietary
Vascular Diseases
Hydrochlorothiazide
Amlodipine
Hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Calcium Channel Blockers
Cardiovascular Agents
 Antihypertensive Agents
Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009



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