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Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00262236
First received: December 2, 2005
Last updated: November 7, 2011
Last verified: June 2006
History of Changes
  Purpose

This is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 weeks.


Condition Intervention Phase
Hypertension
 Drug: Aliskiren
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in diastolic blood pressure after 12 weeks

Secondary Outcome Measures:
  • Change from baseline in systolic blood pressure after 12 weeks
  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks
  • Blood pressure of < 140/90 mmHg after 12 weeks

Enrollment: 693
Study Start Date: November 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  1. Outpatients 18 years of age and older.
  2. Patients with essential hypertension.

Exclusion Criteria:

Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation,

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262236

Locations
Germany
Investigative Centers, Germany
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceutical Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00262236     History of Changes
Other Study ID Numbers: CSPP100A2304
Study First Received: December 2, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Hypertension, Aliskiren, Atenolol, Blood Pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013