Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698646

Enrollment

384

Registered

2008-06-17

Start date

2008-04-30

Completion date

2009-06-30

Last updated

2011-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Systolic blood pressure, Diastolic blood pressure, Valsartan, Hydrochlorothiazide

Brief 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

Interventions

DRUGValsartan + 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.

DRUGValsartan

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.

DRUGHCTZ

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline and Week 4

Secondary

Measure	Time frame	Description
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline and Weeks 4, 8, 12 and 16	—
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline and Weeks 8, 12, and 16	—
Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Weeks 4, 8, 12 and 16	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)	Weeks 4, 8, 12 and 16	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])	During 16 weeks	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Valsartan At week 0 patients received Valsartan 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	128
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.	128
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.	128
Total	384

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Administrative problems	1	0	1
Overall Study	Adverse Event	8	7	8
Overall Study	Lost to Follow-up	0	0	2
Overall Study	Protocol Deviation	6	2	3
Overall Study	Unsatisfactory Therapeutic Effect	11	11	7
Overall Study	Withdrawal by Subject	10	11	8

Baseline characteristics

Characteristic	Valsartan	HCTZ	Valsartan + HCTZ	Total
Age Continuous	77.7 years STANDARD_DEVIATION 4.22	77.7 years STANDARD_DEVIATION 4.8	77.2 years STANDARD_DEVIATION 3.99	77.5 years STANDARD_DEVIATION 4.34
Age, Customized 70-75 years	41 participants	41 participants	44 participants	126 participants
Age, Customized 76-80 years	60 participants	56 participants	65 participants	181 participants
Age, Customized >80 years	27 participants	31 participants	19 participants	77 participants
Sex: Female, Male Female	81 Participants	62 Participants	71 Participants	214 Participants
Sex: Female, Male Male	47 Participants	66 Participants	57 Participants	170 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	16 / 128	27 / 128	23 / 128
serious Total, serious adverse events	3 / 128	4 / 128	3 / 128

Outcome results

Primary

Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

Time frame: Baseline and Week 4

Population: Intent to treat (ITT), Last observation carried forward

Arm	Measure	Group	Value (MEAN)	Dispersion
Valsartan	Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 4	157.5 mm Hg	Standard Deviation 19.71
Valsartan	Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline	166.2 mm Hg	Standard Deviation 11.07
Valsartan	Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 4	-8.6 mm Hg	Standard Deviation 19.47
HCTZ	Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 4	150.9 mm Hg	Standard Deviation 18.41
HCTZ	Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline	164.5 mm Hg	Standard Deviation 11.84
HCTZ	Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 4	-13.6 mm Hg	Standard Deviation 16.81
Valsartan + HCTZ	Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline	164.5 mm Hg	Standard Deviation 11.86
Valsartan + HCTZ	Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 4	-17.3 mm Hg	Standard Deviation 17.61
Valsartan + HCTZ	Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 4	147.1 mm Hg	Standard Deviation 18.35

Secondary

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

Population: Intent to treat (ITT), Last observation carried forward

Arm	Measure	Group	Value (MEAN)	Dispersion
Valsartan	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 8	78.3 mm Hg	Standard Deviation 10.33
Valsartan	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 16	-7.1 mm Hg	Standard Deviation 10.78
Valsartan	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 12	77.6 mm Hg	Standard Deviation 11
Valsartan	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 8	-6.6 mm Hg	Standard Deviation 10.26
Valsartan	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline	84.9 mm Hg	Standard Deviation 9.78
Valsartan	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 16	77.8 mm Hg	Standard Deviation 10.34
Valsartan	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 4	-3.9 mm Hg	Standard Deviation 9.08
Valsartan	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 4	81.0 mm Hg	Standard Deviation 10.61
Valsartan	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 12	-7.3 mm Hg	Standard Deviation 10.55
HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 8	-6.4 mm Hg	Standard Deviation 10.72
HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline	85.5 mm Hg	Standard Deviation 9.09
HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 4	81.6 mm Hg	Standard Deviation 10.97
HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 4	-3.9 mm Hg	Standard Deviation 10.24
HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 8	79.1 mm Hg	Standard Deviation 11.97
HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 12	78.1 mm Hg	Standard Deviation 11.42
HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 12	-7.3 mm Hg	Standard Deviation 10.75
HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 16	77.9 mm Hg	Standard Deviation 11.66
HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 16	-7.5 mm Hg	Standard Deviation 10.76
Valsartan + HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 4	-7.1 mm Hg	Standard Deviation 8.8
Valsartan + HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline	84.8 mm Hg	Standard Deviation 9.36
Valsartan + HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 12	-9.5 mm Hg	Standard Deviation 9.66
Valsartan + HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 4	77.8 mm Hg	Standard Deviation 9.66
Valsartan + HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 16	-8.3 mm Hg	Standard Deviation 8.62
Valsartan + HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Change in MSDBP from Baseline to Week 8	-8.4 mm Hg	Standard Deviation 9.68
Valsartan + HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 8	76.5 mm Hg	Standard Deviation 9.45
Valsartan + HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 16	76.6 mm Hg	Standard Deviation 8.42
Valsartan + HCTZ	Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)	Week 12	75.4 mm Hg	Standard Deviation 8.87

Secondary

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

Population: Intent to treat (ITT), Last observation carried forward

Arm	Measure	Group	Value (MEAN)	Dispersion
Valsartan	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline	166.2 mm Hg	Standard Deviation 11.07
Valsartan	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 16	-17.5 mm Hg	Standard Deviation 19.62
Valsartan	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 12	148.6 mm Hg	Standard Deviation 21.45
Valsartan	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 16	148.7 mm Hg	Standard Deviation 20.06
Valsartan	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 8	150.4 mm Hg	Standard Deviation 20.29
Valsartan	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 12	-17.5 mm Hg	Standard Deviation 21.16
Valsartan	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 8	-15.7 mm Hg	Standard Deviation 20.43
HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 12	-19.4 mm Hg	Standard Deviation 19.19
HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 16	144.9 mm Hg	Standard Deviation 19.59
HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 16	-19.7 mm Hg	Standard Deviation 19.69
HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 8	-17.1 mm Hg	Standard Deviation 17.83
HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline	164.5 mm Hg	Standard Deviation 11.84
HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 12	145.1 mm Hg	Standard Deviation 19.38
HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 8	147.4 mm Hg	Standard Deviation 18.69
Valsartan + HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 16	-20.9 mm Hg	Standard Deviation 18.49
Valsartan + HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 8	144.2 mm Hg	Standard Deviation 19.93
Valsartan + HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 8	-20.2 mm Hg	Standard Deviation 19.12
Valsartan + HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 12	142.0 mm Hg	Standard Deviation 18.78
Valsartan + HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Change in MSSBP from Baseline to Week 12	-22.5 mm Hg	Standard Deviation 19.52
Valsartan + HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Week 16	143.5 mm Hg	Standard Deviation 18.69
Valsartan + HCTZ	Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline	164.5 mm Hg	Standard Deviation 11.86

Secondary

Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)

Cumulative refers to achieving blood pressure goal before or at the corresponding visit.

Time frame: Weeks 4, 8, 12 and 16

Population: Intent to treat (ITT)

Arm	Measure	Group	Value (NUMBER)
Valsartan	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 4	25 Percentage of Participants
Valsartan	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 8	40.63 Percentage of Participants
Valsartan	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 12	50 Percentage of Participants
Valsartan	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 16	56.25 Percentage of Participants
HCTZ	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 16	68.25 Percentage of Participants
HCTZ	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 4	38.89 Percentage of Participants
HCTZ	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 12	62.70 Percentage of Participants
HCTZ	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 8	52.38 Percentage of Participants
Valsartan + HCTZ	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 16	72.22 Percentage of Participants
Valsartan + HCTZ	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 8	63.49 Percentage of Participants
Valsartan + HCTZ	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 12	69.05 Percentage of Participants
Valsartan + HCTZ	Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Week 4	49.21 Percentage of Participants

Secondary

Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg

Cumulative refers to achieving of blood pressure control before or at the corresponding visit.

Time frame: Weeks 4, 8, 12 and 16

Population: Intent to treat (ITT)

Arm	Measure	Group	Value (NUMBER)
Valsartan	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 4	25 Percentage of Participants
Valsartan	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 8	40.63 Percentage of Participants
Valsartan	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 12	50 Percentage of Participants
Valsartan	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 16	55.47 Percentage of Participants
HCTZ	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 16	66.67 Percentage of Participants
HCTZ	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 4	37.3 Percentage of Participants
HCTZ	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 12	61.11 Percentage of Participants
HCTZ	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 8	50.79 Percentage of Participants
Valsartan + HCTZ	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 16	72.22 Percentage of Participants
Valsartan + HCTZ	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 8	63.49 Percentage of Participants
Valsartan + HCTZ	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 12	69.05 Percentage of Participants
Valsartan + HCTZ	Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg	Week 4	49.21 Percentage of Participants

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])

Time frame: During 16 weeks

Population: Intent to treat (ITT)

Arm	Measure	Value (MEDIAN)
Valsartan	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 Weeks
HCTZ	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])	8.0 Weeks
Valsartan + HCTZ	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])	4.0 Weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)

Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)

Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg

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])