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A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00219089
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 17, 2017
Information provided by (Responsible Party):

Brief Summary:
To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus

Condition or disease Intervention/treatment Phase
Hypertension, Diabetes Mellitus Drug: aliskiren Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 839 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Eight-week, Randomized, Double-blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus
Study Start Date : November 2004
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcome Measures :
  1. Change from baseline to week 4 endpoint in mean sitting diastolic blood pressure
  2. Change from baseline to week 8 endpoint in mean sitting systolic blood pressure
  3. Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Patients with essential hypertension
  • Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
  • Patients who are eligible and able to participate in the study

Exclusion Criteria

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219089

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Investigative Centers, Germany
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219089     History of Changes
Other Study ID Numbers: CSPP100A2307
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Novartis:
Hypertension, aliskiren, blood pressure, diabetes mellitus, ramipril

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents