Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00698646
First received: June 13, 2008
Last updated: April 15, 2011
Last verified: April 2011
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Purpose
The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Valsartan + HCTZ Drug: Valsartan Drug: HCTZ |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A 16 Week Multi-center, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Valsartan/Hydrochlorothiazide (HCTZ) Combination Therapy Compared to Patients Initiated With Valsartan Monotherapy or Hydrochlorothiazide (HCTZ) Monotherapy in Very Elderly Patients With Essential Hypertension |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline and Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
- Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Weeks 8, 12, and 16 ] [ Designated as safety issue: No ]
- Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg [ Time Frame: Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]Cumulative refers to achieving of blood pressure control before or at the corresponding visit.
- Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg) [ Time Frame: Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]Cumulative refers to achieving blood pressure goal before or at the corresponding visit.
- Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg]) [ Time Frame: During 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 384 |
| Study Start Date: | April 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Valsartan
(patients initiated on valsartan)
|
Drug: Valsartan
At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
|
Active Comparator: HCTZ
(patients initiated on HCTZ)
|
Drug: HCTZ
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
|
|
Experimental: Valsartan + HCTZ
(patients initiated on Valsartan+HCTZ)
|
Drug: Valsartan + HCTZ
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 70 years or older.
- Patients with hypertension prior to being randomized into study.
- Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
- Have the ability to communicate and comply with all study requirements.
- Provide written informed consent to participate in the study prior to any screening or study procedures.
Exclusion Criteria:
- Use of other investigational drugs within 30 days of enrollment.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
- Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
- Other protocol-defined exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698646
Locations
| United States, Alabama | |
| Investigative site | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Investigative site | |
| Phoenix, Arizona, United States | |
| United States, California | |
| Investigative Site | |
| Escondido, California, United States | |
| Investigative site | |
| Fresno, California, United States | |
| Investigative site | |
| Huntington Park, California, United States | |
| Investigative Sites | |
| Pismo Beach, California, United States | |
| United States, Florida | |
| Investigative site | |
| Miami, Florida, United States | |
| Investigative site | |
| Ormond Beach, Florida, United States | |
| United States, Georgia | |
| Investigative site | |
| Conyers, Georgia, United States | |
| United States, Kentucky | |
| Investigative Site | |
| Lexington, Kentucky, United States | |
| United States, Maine | |
| Investigative site | |
| Portland, Maine, United States | |
| United States, Nevada | |
| Investigative site | |
| Las Vegas, Nevada, United States | |
| United States, New York | |
| Investigative site | |
| Buffalo, New York, United States | |
| United States, North Carolina | |
| Investigative site | |
| Shelby, North Carolina, United States | |
| United States, Ohio | |
| Investigative site | |
| Carlisle, Ohio, United States | |
| United States, Oklahoma | |
| Investigative site | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Investigative site | |
| Erie, Pennsylvania, United States | |
| United States, South Carolina | |
| Investigative Site | |
| Greer, South Carolina, United States | |
| Investigative Site | |
| Taylors, South Carolina, United States | |
| United States, Utah | |
| Investigative site | |
| St George, Utah, United States | |
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
Additional Information:
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00698646 History of Changes |
| Other Study ID Numbers: | CVAH631BUS08 |
| Study First Received: | June 13, 2008 |
| Results First Received: | November 16, 2010 |
| Last Updated: | April 15, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Novartis:
|
Systolic blood pressure Diastolic blood pressure Valsartan Hydrochlorothiazide |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Valsartan 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 II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013