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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00739973

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren Drug: Amlodipine Drug: Aliskiren/amlodipine Drug: Placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: 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: 10-12.5 weeks ] [ Designated as safety issue: No ]

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 ]

Estimated Enrollment:	1611
Study Start Date:	September 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren 150 mg	Drug: Aliskiren Aliskiren 150 mg
2: Experimental Aliskiren 300 mg	Drug: Aliskiren Aliskiren 300 mg
3: Experimental Amlodipine 5mg	Drug: Amlodipine Amlodipine 5mg
4: Experimental Amlodipine 10 mg	Drug: Amlodipine Amlodipine 10 mg
5: Experimental Aliskiren/amlodipine 150/5 mg	Drug: Aliskiren/amlodipine Aliskiren/amlodipine 150/5 mg
6: Experimental Aliskiren/amlodipine 150/10 mg	Drug: Aliskiren/amlodipine Aliskiren/amlodipine 150/10 mg
7: Experimental Aliskiren/amlodipine 300/5 mg	Drug: Aliskiren/amlodipine Aliskiren/amlodipine 300/5 mg
8: Experimental Aliskiren/amlodipine 300/10 mg	Drug: Aliskiren/amlodipine Aliskiren/amlodipine 300/10mg
9: Experimental Placebo	Drug: Placebo Placebo

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739973

Contacts

Contact: Novartis

862-778-8300

Show 19 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPA100A2305
Study First Received:	August 20, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00739973 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Greece: National Organization of Medicines; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Italy: National Institute of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; South Africa: Medicines Control Council; Taiwan: Department of Health; United States: Food and Drug Administration; Dominican Republic: CONABIOS; Panama: Commemorative Institute GORGAS of Studies of Health; Mexico: National Institute of Public Health, Health Secretariat; Romania: National Medicines Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:

Hypertension, Aliskiren, Amlodipine

Study placed in the following topic categories:

Calcium, Dietary
Vasodilator Agents
Essential Hypertension
Vascular Diseases
Calcium Channel Blockers

Cardiovascular Agents
Antihypertensive Agents
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Amlodipine
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009