Phase 4
Completed N=384
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.
Source: ClinicalTrials.gov NCT00698646 ↗Enrolled (actual)
384
Serious AEs
2.6%
Results posted
Dec 2010
Primary outcomePrimary: Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) — 166.2; 164.5; 164.5; 157.5 mm Hg
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) |
166.2; 164.5; 164.5; 157.5; 150.9; 147.1 | — |
| SECONDARY Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP) |
84.9; 85.5; 84.8; 81.0; 81.6; 77.8 | — |
| SECONDARY Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) |
166.2; 164.5; 164.5; 150.4; 147.4; 144.2 | — |
| SECONDARY Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg |
25; 37.3; 49.21; 40.63; 50.79; 63.49 | — |
| SECONDARY Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg) |
25; 38.89; 49.21; 40.63; 52.38; 63.49 | — |
| SECONDARY 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]) |
12.0; 8.0; 4.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00698646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.