HypertensionPhase 4NCT03667677
Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety
A Phase 4 study testing Tandospirone + Amlodipine in people with Hypertension and Anxiety, run by Chongqing Medical University at 7 sites in China.
Trial summary
This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Anxiety
- What is being tested?
- Tandospirone + Amlodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 7 sitesChina
- Study dates
- 1 Feb 2019to 1 Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An age of 60 - 80 years old;
- Mild or moderate hypertension diagnosed in previous or at screening (office systolic blood pressure ≥ 140 mm Hg and ≤ 180 mm Hg, or diastolic blood pressure ≥ 90 mm Hg and ≤ 110 mm Hg, or both, on three readings on separate days when not taking any blood pressure drugs) ,and the blood pressure still meet the above criteria after the run-in period;
- A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder;
- Informed consent signed.
Who cannot join
- Secondary hypertension;
- Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg
- Hypertension with target organ damage;
- Cerebral hemorrhage, ischemic cerebral infarction, coronary artery disease, myocardial infarction, second-degree or third-degree atrioventricular block, sick sinus syndrome, atrial fibrillation, left ventricular hypertrophy, cardiac insufficiency (NYHA class Ⅱ-Ⅳ);
- Diabetes and dyslipidemia;
- Asthma, chronic obstructive pulmonary disease, bronchiectasis, and respiratory failure;
Show all 17Show fewer
- Inflammatory bowel disease, active gastritis, pancreatitis, partial or complete intestinal obstruction, and chronic diarrhea;
- Acute or chronic hepatitis, hepatic insufficiency (ALT or AST is more than 2 times the upper limit of normal), and renal insufficiency (serum creatinine > 130 umol / L);
- Uncontrolled thyroid diseases;
- Severe or unstable central nervous system diseases;
- Schizophrenia, bipolar disorder, severe intellectual disability, or severe cognitive impairment;
- Having been diagnosed with alcohol or drug abuse within the past 1 year;
- Presenting the risk of suicide, self-injury, and hurt others;
- Having participated in other clinical studies within the past 3 months;
- Having been treated with anxiolytics, antidepressants, antipsychotics within the past 4 weeks, or have contraindications to the study medications.
- Breastfeeding, pregnancy, or a pregnancy plan during the study;
- Other diseases which the responsible clinician judged that a change in current therapy would place the participant at risk.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Friendship Hospital of Capital Medical University
Beijing, Beijing Municipality
Beijing Haidian Section of Peking University Third Hospital
Beijing, Beijing Municipality
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality
Yongchuan Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Zhongda Hospital of Southeast University
Nanjing, Giangsu
the First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi
Kailuan General Hospital
Tangshan, Hebei
About this study
Official title: Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety: a Multicentre, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial
This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.
Read the detailed description
In recent years, many studies have found that elevated blood pressure is associated with anxiety. It has been report that the incidence of hypertension with anxiety is 25%-54%. The studies have confirmed that anxiety can significantly reduce the antihypertensive effect. Therefore, anxiolytics can increase the antihypertensive effect in patients with hypertension and anxiety. However, there is currently no standard treatment for patients with hypertension and anxiety, and few clinical studies have focused on the treatment of these neglected patients. Improvement on hypertension through relieving anxiety and relief of anxiety through lowering hypertension are lack of clinical studies to prove. This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.
- Conditions
- Hypertension, Anxiety
- Being tested
- Tandospirone + Amlodipine, Tandospirone placebo + Amlodipine, Tandospirone + Amlodipine placebo, Tandospirone placebo + Amlodipine placebo
- Keywords
- Hypertension, Anxiety, Tandospirone, Amlodipine
- Medical subject headings
- Hypertension, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandospirone + AmlodipineDrug
The first group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).
Tandospirone placebo + AmlodipineDrug
The second group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).
Tandospirone + Amlodipine placeboDrug
The third group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).
Tandospirone placebo + Amlodipine placeboDrug
The fourth group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Tandospirone + Amlodipine Receives: Drug: Tandospirone + Amlodipine |
| Group 2 | Experimental | Tandospirone placebo + Amlodipine Receives: Drug: Tandospirone placebo + Amlodipine |
| Group 3 | Experimental | Tandospirone + Amlodipine placebo Receives: Drug: Tandospirone + Amlodipine placebo |
| Group 4 | Placebo comparator | Tandospirone placebo + Amlodipine placebo Receives: Drug: Tandospirone placebo + Amlodipine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office systolic blood pressure and diastolic blood pressure
Measured: Change from Baseline Office systolic blood pressure and diastolic blood pressure at 4 weeks and 8 weeks
14-item Hamilton Anxiety Scale(HAMA)
HAMA-14 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 56. 29 or more on HAMA means severe anxiety disorders, 21 to 28 on HAMA means obvious anxiety disorders, 14 to 20 on HAMA means anxiety disorders, 8 to 13 on HAMA means suspicious anxiety disorders, 7 or less means no anxiety disorders.
Measured: Change from Baseline HAMA score at 4 weeks and 8 weeks
Secondary outcomes (9)
the proportion of patients who met blood pressure control goal( < 140/90mmHg)
Measured: Week 8
24-hour ambulatory blood pressure monitoring(ABPM)
Measured: Change from Baseline ABPM at 4 weeks and 8 weeks
the proportion of participants with an at least 50% reduction of HAMA score from baseline
Measured: Week 8
the proportion of participants showing 7 or less on HAMA
Measured: Week 8
20-item Self-Rating Anxiety Scale(SAS)
SAS-20 are rated on 4 grades ranging from 1(a little of the time) to 4(most of the time).The standard score ranges are 25-49 (normal range), 50-59 (mild anxiety), 60-69(moderate anxiety), and 70 or more(severe anxiety).
Measured: Change from Baseline SAS score at 4 weeks and 8 weeks
heart rate variability(HRV)
Measured: Change from Baseline HRV at 4 weeks and 8 weeks
17-item Hamilton Depression Rating Scale(HAMD)
HAMD-17 are rated on 5 grades ranging from 0 (no symptom) to 4 (very severe). 7 or less on HAMD means no depression, 7 to 17 on HAMD means mild depression, 18 to 23 on HAMD means moderate depression, and 24 or more on HAMD means severe depression.
Measured: Change from Baseline HAMD score at 4 weeks and 8 weeks
Clinical Global Impression-Improvement(CGI-I)
Measured: Change from Baseline CGI-I score at 4 weeks and 8 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire(Q-LES-Q)
Q-LES-Q are rated on 5 grades ranging from 1 to 5 points.
Measured: Change from Baseline Q-LES-Q score at 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Feb 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Peng, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667677
- Sponsor's protocol ID
- CES-TAHA
- Status last verified
- Nov 2018
- First submitted
- 6 Sep 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any public report on the results of this study will not disclose personal information of the participants.
Publications
Bhattacharya R, Shen C, Sambamoorthi U. Excess risk of chronic physical conditions associated with depression and anxiety. BMC Psychiatry. 2014 Jan 16;14:10. doi: 10.1186/1471-244X-14-10.
PubMed 24433257Pan Y, Cai W, Cheng Q, Dong W, An T, Yan J. Association between anxiety and hypertension: a systematic review and meta-analysis of epidemiological studies. Neuropsychiatr Dis Treat. 2015 Apr 22;11:1121-30. doi: 10.2147/NDT.S77710. eCollection 2015.
PubMed 25960656Byrd JB, Brook RD. Anxiety in the "age of hypertension". Curr Hypertens Rep. 2014 Oct;16(10):486. doi: 10.1007/s11906-014-0486-0.
PubMed 25164965Kretchy IA, Owusu-Daaku FT, Danquah SA. Mental health in hypertension: assessing symptoms of anxiety, depression and stress on anti-hypertensive medication adherence. Int J Ment Health Syst. 2014 Jun 21;8:25. doi: 10.1186/1752-4458-8-25. eCollection 2014.
PubMed 24987456
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety: a Multicentre, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03667677
- Acronym / sponsor ID
- CES-TAHA
- Conditions
- Hypertension, Anxiety
- Keywords
- Hypertension, Anxiety, Tandospirone, Amlodipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.
Detailed description
In recent years, many studies have found that elevated blood pressure is associated with anxiety. It has been report that the incidence of hypertension with anxiety is 25%-54%. The studies have confirmed that anxiety can significantly reduce the antihypertensive effect. Therefore, anxiolytics can increase the antihypertensive effect in patients with hypertension and anxiety. However, there is currently no standard treatment for patients with hypertension and anxiety, and few clinical studies have focused on the treatment of these neglected patients. Improvement on hypertension through relieving anxiety and relief of anxiety through lowering hypertension are lack of clinical studies to prove. This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Tandospirone + AmlodipineTandospirone + Amlodipine |
| Group 2 | Experimental | Drug: Tandospirone placebo + AmlodipineTandospirone placebo + Amlodipine |
| Group 3 | Experimental | Drug: Tandospirone + Amlodipine placeboTandospirone + Amlodipine placebo |
| Group 4 | Placebo comparator | Drug: Tandospirone placebo + Amlodipine placeboTandospirone placebo + Amlodipine placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An age of 60 - 80 years old;
- Mild or moderate hypertension diagnosed in previous or at screening (office systolic blood pressure ≥ 140 mm Hg and ≤ 180 mm Hg, or diastolic blood pressure ≥ 90 mm Hg and ≤ 110 mm Hg, or both, on three readings on separate days when not taking any blood pressure drugs) ,and the blood pressure still meet the above criteria after the run-in period;
- A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder;
- Informed consent signed.
Key exclusion criteria (17 listed)
- Secondary hypertension;
- Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg
- Hypertension with target organ damage;
- Cerebral hemorrhage, ischemic cerebral infarction, coronary artery disease, myocardial infarction, second-degree or third-degree atrioventricular block, sick sinus syndrome, atrial fibrillation, left ventricular hypertrophy, cardiac insufficiency (NYHA class Ⅱ-Ⅳ);
- Diabetes and dyslipidemia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tandospirone + AmlodipineThe first group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day). | Drug | Group 1 |
| Tandospirone placebo + AmlodipineThe second group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day). | Drug | Group 2 |
| Tandospirone + Amlodipine placeboThe third group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day). | Drug | Group 3 |
| Tandospirone placebo + Amlodipine placeboThe fourth group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day). | Drug | Group 4 |
Primary outcome
Office systolic blood pressure and diastolic blood pressure
Time frame: Change from Baseline Office systolic blood pressure and diastolic blood pressure at 4 weeks and 8 weeks
14-item Hamilton Anxiety Scale(HAMA)
Time frame: Change from Baseline HAMA score at 4 weeks and 8 weeks
HAMA-14 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 56. 29 or more on HAMA means severe anxiety disorders, 21 to 28 on HAMA means obvious anxiety disorders, 14 to 20 on HAMA means anxiety disorders, 8 to 13 on HAMA means suspicious anxiety disorders, 7 or less means no anxiety disorders.
9 secondary outcomes
the proportion of patients who met blood pressure control goal( < 140/90mmHg)
Time frame: Week 8
24-hour ambulatory blood pressure monitoring(ABPM)
Time frame: Change from Baseline ABPM at 4 weeks and 8 weeks
the proportion of participants with an at least 50% reduction of HAMA score from baseline
Time frame: Week 8
the proportion of participants showing 7 or less on HAMA
Time frame: Week 8
20-item Self-Rating Anxiety Scale(SAS)
Time frame: Change from Baseline SAS score at 4 weeks and 8 weeks
heart rate variability(HRV)
Time frame: Change from Baseline HRV at 4 weeks and 8 weeks
17-item Hamilton Depression Rating Scale(HAMD)
Time frame: Change from Baseline HAMD score at 4 weeks and 8 weeks
Clinical Global Impression-Improvement(CGI-I)
Time frame: Change from Baseline CGI-I score at 4 weeks and 8 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire(Q-LES-Q)
Time frame: Change from Baseline Q-LES-Q score at 4 weeks and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Background: PubMed 24433257Bhattacharya R, Shen C, Sambamoorthi U. Excess risk of chronic physical conditions associated with depression and anxiety. BMC Psychiatry. 2014 Jan 16;14:10. doi: 10.1186/1471-244X-14-10.
- Background: PubMed 25960656Pan Y, Cai W, Cheng Q, Dong W, An T, Yan J. Association between anxiety and hypertension: a systematic review and meta-analysis of epidemiological studies. Neuropsychiatr Dis Treat. 2015 Apr 22;11:1121-30. doi: 10.2147/NDT.S77710. eCollection 2015.
- Background: PubMed 25164965Byrd JB, Brook RD. Anxiety in the "age of hypertension". Curr Hypertens Rep. 2014 Oct;16(10):486. doi: 10.1007/s11906-014-0486-0.
- Background: PubMed 24987456Kretchy IA, Owusu-Daaku FT, Danquah SA. Mental health in hypertension: assessing symptoms of anxiety, depression and stress on anti-hypertensive medication adherence. Int J Ment Health Syst. 2014 Jun 21;8:25. doi: 10.1186/1752-4458-8-25. eCollection 2014.
- Individual participant dataSharing planned: No. Any public report on the results of this study will not disclose personal information of the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tandospirone + Amlodipine in people with Hypertension and Anxiety, run by Chongqing Medical University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Xie (86-023-68485490, xiepeng@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office systolic blood pressure and diastolic blood pressure (time frame: Change from Baseline Office systolic blood pressure and diastolic blood pressure at 4 weeks and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03667677, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.