A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219063
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: June 2006
  Purpose

To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.


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 26 Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing Aliskiren to Ramipril With Optional Addition of Hydrochlorothiazide, Followed by a 4 Week Double-blind, Randomized, Placebo-controlled Withdrawal in Patients With Essential Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in diastolic blood pressure after 26 weeks

Secondary Outcome Measures:
  • Change from baseline in systolic blood pressure after 26 weeks
  • Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks
  • Change from baseline in systolic blood pressure after 6 weeks and 12 weeks
  • Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 weeks

Enrollment: 844
Study Start Date: February 2005
Study Completion Date: March 2006
Primary Completion Date: March 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

  • Patients with essential hypertension
  • 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 inclusion exclusion criteria also apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219063

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219063     History of Changes
Other Study ID Numbers: CSPP100A2306
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension, aliskiren, blood pressure, Ramipril, hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Ramipril
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014