To Find Out Whether Valsartan With or Without Other Blood Pressure Medications Would Improve the Ability of the Heart to Fill and Empty, and the Ability of the Heart Muscle to Relax Adequately in People With High Blood Pressure.
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00170924
First received: September 10, 2005
Last updated: November 7, 2011
Last verified: November 2011
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Purpose
Patients who have had high blood pressure for a long time may have diastolic dysfunction. Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing adequately.
This study is to find out if Valsartan) will improve the ability of the heart to fill, empty, and relax appropriately when given alone or with other medicines to treat high blood pressure.
| Condition | Intervention | Phase |
|---|---|---|
|
Diastolic Dysfunction Hypertension |
Drug: Valsartan |
Phase 4 |
| 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 Multi-center, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of the Angiotensin II Antagonist Valsartan on Diastolic Function in Patients With Hypertension and Diastolic Dysfunction |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram
Secondary Outcome Measures:
- Change from baseline in the wall thickness of left heart ventricle after 38 weeks
- Change from baseline in the size (mass) left heart ventricle after 38 weeks
- Change from baseline in heart function after 38 weeks
- Change from baseline in circulating marker of ventricular function after 38 weeks
- Change from baseline in circulating marker of inflammation
| Enrollment: | 317 |
| Study Start Date: | August 2004 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Diagnosis/History of high blood pressure
- Male or Female age 45 years or older
Exclusion Criteria:
- History of stroke, transient ischemic attack or heart attack within the last 6 months
- A hospital admission for congestive heart failure within the last year
- Use of certain high blood pressure medications such as ACE inhibitors, Angiotensin Receptor Blockers or aldosterone antagonists or other agents that may work in the same pathway (RAAS) as valsartan within the past 3 months.
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: NCT00170924
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170924
Locations
| United States, New Jersey | |
| Novartis Pharmaceuticals | |
| East Hanover, New Jersey, United States, 07936 | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00170924 History of Changes |
| Other Study ID Numbers: | CVAL489AUS52 |
| Study First Received: | September 10, 2005 |
| Last Updated: | November 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Hypertension, High Blood Pressure, Diastolic Dysfunction, Heart Disease |
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 September 30, 2016