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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00698646
First received: June 13, 2008
Last updated: April 15, 2011
Last verified: April 2011
  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
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: 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 July 29, 2014