A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients
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ClinicalTrials.gov Identifier: NCT00219193 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: February 7, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: aliskiren | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 641 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | January 2007 |
- Change from baseline in diastolic blood pressure after 8 weeks
- 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

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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 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.

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): NCT00219193
United States, New Jersey | |
Novartis Pharmaceuticals | |
East Hanover, New Jersey, United States, 07936 | |
Germany | |
Investigative Centers, Germany |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Additional Information:
Publications of Results:
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT00219193 History of Changes |
Other Study ID Numbers: |
CSPP100A2331 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | February 7, 2017 |
Last Verified: | February 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 |