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A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219193
First received: September 12, 2005
Last updated: February 3, 2017
Last verified: February 2017
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Purpose
To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: aliskiren | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (masked roles unspecified) Primary Purpose: Treatment |
| Official Title: | An Eight Week, Multicenter Study to Evaluate Efficacy and Safety of the Triple Combo of Aliskiren /Valsartan/HCTZ (300/320/25 mg), Compared to the Double Combos of Aliskiren/HCTZ (300/25 mg) or Valsartan/HCTZ (320/25 mg) in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change from baseline in diastolic blood pressure after 8 weeks
Secondary Outcome Measures:
- Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks
- Change from baseline in standing blood pressure after 4 weeks and 8 weeks
- Achieve blood pressure control target of < 140/90 mmHg after 8 weeks
| Enrollment: | 641 |
| Study Start Date: | October 2005 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Other protocol-defined exclusion criteria may 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: NCT00219193
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219193
Locations
| United States, New Jersey | |
| Novartis Pharmaceuticals | |
| East Hanover, New Jersey, United States, 07936 | |
| Germany | |
| Investigative Centers, Germany | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
Publications:
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00219193 History of Changes |
| Other Study ID Numbers: |
CSPP100A2331 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 3, 2017 |
Keywords provided by Novartis:
|
Hypertension, aliskiren, blood pressure, valsartan, HCTZ |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Valsartan |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 23, 2017