ClinicalTrials.gg
Status unknownNCT03432468Updated Mar 13, 2018

Effect of Fully Blocking Type 1 Angiotensin Receptor on Target Organ Damage of Postmenopausal Hypertensive Women

An interventional study of Valsartan 1 and Valsartan 80 mg in Hypertension, sponsored by LanZhou University. Status unknown. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by LanZhou University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 140 studies testing valsartan in Hypertension — none open to participants now, none under way, none of them phase 3. Valsartan · Hypertension.

Planned enrollment
95th of 139
102 · median 198
Started
2018
with 3 others
No phase
5 of 140
none open now
Registered
131st of 140
by date
Lead sponsor
2 of 140
LanZhou University

Among the 140 studies testing valsartan in Hypertension, this one is the 95th largest by planned enrollment of the 139 interventional ones that give a count, is one of 4 that started in 2018, is one of 5 with no phase, and was the 131st registered.

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 102 is close to the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Open to participants now

None of the 140 studies testing valsartan in Hypertension is open now.

About valsartan

Valsartan: first FDA approval 1996 (DIOVAN), first EMA approval 2007. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.

This study: 40 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Download CSVNarrow it in search →With an account: the 140 studies testing valsartan in Hypertension as a file.
02

Study summary

This study compared the improvements of blood pressure levels, left ventricular hypertrophy, left ventricular diastolic function, vascular function and cognitive function between postmenopausal hypertensive women and age-matched hypertensive male patients through the evaluation of the effects of fully blocked AT1 receptor by valsartan. Additionally, the differences of the above indexes between the patients who were fully blocked AT1 receptor by valsartan and the patients who were treated with a single dose of valsartan treatment were assessed, so as to provide theory basis for clinical treatment of postmenopausal hypertensive women.

03

Conditions studied

  • Hypertension

Keywords

  • Hypertension
  • Left Ventricular Hypertrophy
  • Women
04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of hypertension
  • Women are all
  • Must provide written

Exclusion criteria

Exclusion Criteria:

  • Secondary hypertension
  • Coronary disease
  • Heart failure
  • Arterial fibrillation
  • Previous myocardial infarction
  • Previous stroke
  • Malignant disease
  • Kidney failure
  • Liver failure
  • Neoplastic disease
  • Severe neurological diseases
  • Severe metabolic or organic decompensation
  • Refuse to sign the form
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Active comparator
    postmenopausal hypertensive women

    Drug: Valsartan 1 · Drug: Valsartan 80 mg

  • Placebo comparator
    age-matched hypertensive male patients

    Drug: Valsartan 1

Interventions

  • DrugValsartan 1

    the high dose of valsartan

  • a single dose of valsartan

06

What researchers measure

Primary outcomes

  1. Relative indexes of myocardial remodeling

    Cardiac structure (left ventricular mass index in grams for square meter) measurement.

    Time frame: Change from Baseline left ventricular mass index at 6 months.

  2. Relative indexes of myocardial remodeling

    Cardiac structure (left ventricular mass index in grams for square meter) measurement.

    Time frame: Change from Baseline left ventricular mass index at 12 months.

  3. Ambulatory blood pressure monitoring

    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.

    Time frame: Change from Baseline ABPM at 6 months.

  4. Ambulatory blood pressure monitoring

    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.

    Time frame: Change from Baseline ABPM at 12 months.

  5. Sexual hormones

    Blood samples used to analyze the levels of sexual hormones were collected between morning 8:00 and 9:00 after an overnight fast. The sexual hormones which include prolactin (PRL) and progesterone (P) units on nanogram per millilitre, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) units on millionInternationalUnits per millilitre, testosterone (T) in nanogram per deciliter, estradiol (E2) in picogram per millilitre.

    Time frame: Baseline sexual hormones.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2018; primary completion for Aug 2019, 16 months later.

Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 16 months is below that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2018
First posted
Feb 14, 2018
StartEst.
Apr 1, 2018
Primary completionEst.
Aug 1, 2019
CompletionEst.
Aug 1, 2019
Last update
Mar 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03432468
Lead sponsor
LanZhou University
Responsible party
Jing Yu (Principal Investigator, LanZhou University) — Principal investigator
First posted
Feb 14, 2018
Start date
Apr 1, 2018 (estimated)
Primary completion
Aug 1, 2019 (estimated)
Completion
Aug 1, 2019 (estimated)
Last update
Mar 13, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Valsartan

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